Mapping Stakeholder Perceptions of Service Quality: Development and Initial Validation of the e-Qual Assessment Tool in Higher Education Institutions | Chapter 1 | Language, Literature and Education: Research Updates Vol. 8

 

The quality of education, especially at the higher education level, is pivotal in shaping employable, globally competitive graduates. Students and families increasingly prioritise institutions recognised for quality education, viewing them as gateways to successful and fulfilling careers. In pursuit of quality and excellence in educational institutions, it is increasingly important to identify the demands and needs of stakeholders. Service quality has been identified as one such demand. The purpose of the current study was to develop and validate a quality service assessment tool based on the SERVQUAL Model to describe the service quality in a Higher Education Institution. This study utilised a development and descriptive-evaluative research design to create and validate a Quality Service Assessment Tool grounded in the SERVQUAL model. The assessment tool was subsequently administered to a total of 105 respondents, comprising students, faculty, non-teaching staff, and external stakeholders. Its distribution via Google Forms enabled a broad reach and convenient data collection. The sources of data were the heads and personnel of the different clusters of CBSUA. The study involved the adaptation and pilot testing of the model tailored for CBSUA offices. The data were treated statistically using the weighted mean and rank. Initial validation of the tool was conducted through pre-testing with a small and diverse group composed of students, faculty, non-teaching staff, and alumni. To ensure the tool's validity, expert review was also conducted. The weighted-mean scores for the five SERVQUAL dimensions across the offices of the University President, Research and Innovation, Administration and Finance, Business and External Affairs, and Academic Cluster demonstrate that respondents find all five dimensions to be appropriate for assessing the service quality of each office. The relatively high scores across all dimensions highlight the importance of Tangibility, Assurance, Reliability, Responsiveness, and Empathy in shaping stakeholders' perceptions and expectations of service quality within an educational institution. While some dimensions hold greater importance for specific offices due to their unique roles and responsibilities, all dimensions are nonetheless essential for evaluating the overall service quality in each context. The findings align with previous research on the applicability of the SERVQUAL model across various contexts, including higher education institutions. Ultimately, the results underline the significance of maintaining a high level of service quality across all dimensions in each office, as this is crucial for ensuring stakeholder satisfaction and fostering a positive reputation for the university. It is suggested that similar research be undertaken across all State Universities and Colleges (SUCs) in the Bicol Region to broaden the scope of validation and applicability.

 

Author(s) Details:-

Melinda Parro-Pan
Central Bicol State University of Agriculture –San Jose, Pili, Camarines Sur, Philippines.

 

 

Please see the book here :- https://doi.org/10.9734/bpi/lleru/v8/6120

 

LC-Based Quantification of Diastereomeric Impurities in Entecavir Drug Substances | Chapter 2 | Pharmaceutical Research: Recent Advances and Trends Vol. 8

This chapter describes a simple, sensitive, and cost-effective mobile phase method for determination and quantitation of diastereomeric impurities of Entecavir in drug substances and drug products. Effective chromatographic separation was achieved on a C18 stationary phase (150 x 4.6 mm, 3.5 microns particles) with the economical and simple mobile phase combination such as water and acetonitrile in the ratio of 95:5 (% v/v) delivered in an isocratic mode at a flow rate of 1.0 mL/min at 254 nm. In the developed method, the resolution between Entecavir and its diastereomeric impurities were found to be greater than 2.0. The linearity of the method was demonstrated by means of correlation Co-efficient square (r2) value for Entecavir and its diastereomeric impurities were found to be greater than 0.999. The limit of detection for imp-1, imp-2, imp-3 and Entecavir were 0.002%, 0.002%, 0.003% and 0.008% and the limit of quantification for imp-1, imp-2, imp-3 and Entecavir were 0.007%, 0.006%, 0.008% and 0.025% respectively. The %recovery for imp-1, imp-2, imp-3 were observed in the range between 95 and 105%. The test solution was found to be stable in the diluent for 48 h. The drug was subjected to stress conditions. The mass balance was found close to 99.5%.

 

Author (s) Details

N Balaji
Analytical Development Laboratory, Apicore LLC, New Jersey, USA.

 

Sayeeda Sultana
Department of Chemistry, St. Peter’s University, Avadi, Chennai- 600 054, Tamil Nadu, India.

 

Please see the book here:- https://doi.org/10.9734/bpi/prrat/v8/2720

UV Spectrophotometric Method Development and Validation for Estimation of Trimetazidine Dihydrochloride in Bulk and Pharmaceutical Dosage Form | Chapter 2 | Pharmaceutical Science: New Insights and Developments Vol. 1

The present study illustrates the development and validation of a new, simple, precise and accurate spectrophotometric method for the determination of Anti-anginal Trimetazidine dihydrochloride (TMZ) in bulk and its dosage forms using Ethanol as solvent. The drug showed its λ max at 233 nm in various concentrations. Under the optimised conditions, linear relationships with good correlation coefficients were found between the concentration ranges of 10-60 µg/ml. The precision of the method was found to be <2% of %RSD. The accuracy of the method was found in the normal ranges i.e., the recovery values were found to be in the range of 97-101%. The LOD and LOQ values of the method were found to be 0.15 and 0.45 µg/ml, respectively. The assay of the method was found in normal values of 98.87%. The proposed method is practical and valuable for its routine application in quality control laboratories for the estimation of TMZ.

 

Author (s) Details

 

G. Sandhya Rani
Department of Pharmaceutical Analysis, Anurag Pharmacy College, Ananthagiri (Vi & Md), Kodad-508206, Telangana (St.), India.

 

L. Phanishabareesh
Anurag Pharmacy College, Ananthagiri (Vi & Md), Kodad-508206, Telangana (St.), India.

 

G. Shiwathmika
Anurag Pharmacy College, Ananthagiri (Vi & Md), Kodad-508206, Telangana (St.), India.

 

SK. Roshan Himad
Anurag Pharmacy College, Ananthagiri (Vi & Md), Kodad-508206, Telangana (St.), India.

 

M. Chinnaeswaraiah
Department of Pharmacognosy, Anurag Pharmacy College, Ananthagiri (Vi & Md), Kodad-508206, Telangana (St.), India.

 

Please see the book here:- https://doi.org/10.9734/bpi/psnid/v1/3370

Stability Indicating UV Spectrophotometric Method Development and Validation of Fisetin in Pure and Pharmaceutical Capsule Dosage Form | Chapter 2 | Pharmaceutical Research: Recent Advances and Trends Vol. 2

 

Objective: The objective of the study was to develop and UV Spectrophotometric method and apply the method to dosage form.

Methods: A simple, precise and sensitive ultraviolet spectrophotometric method was developed for the determination of Fisetin in pure and pharmaceutical capsule dosage form; the spectroscopic method was run through Shimadzu UV-1800 with solvent of Methanol: 0.1%OPA was used in this method-working wavelength was selected at 362nm.

Results: Beer-Lambert’s law revealed a good correlation in the concentration range of 3-15µg/ml. The absorbance was found to be 0.385 with %RSD for interday precision and intraday Precision was 0.53% & 0.51%.

Conclusion: The developed method was successfully applied to the determination of Fisetin in commercially available dosage forms. A statistical comparison of the results showed an insignificant difference between the proposed method and reference method. The proposed methods offered the advantages of simplicity and economy that can be applied without the need for expensive instrumentation and reagents in quality control analysis.

 

Author(s)details:-

 

R. Nageswara Rao
Department of Pharmaceutical Analysis, Santhiram College of Pharmacy, Nandyal-518501, Andhra Pradesh, India.

 

L. Siva Shankar Reddy
Department of Pharmaceutical Analysis, Santhiram College of Pharmacy, Nandyal-518501, Andhra Pradesh, India.

 

N. Madangopal
Department of Pharmaceutical Analysis, Santhiram College of Pharmacy, Nandyal-518501, Andhra Pradesh, India.

 

M Lakshmi Devi
Department of Pharmaceutical Analysis, Santhiram College of Pharmacy, Nandyal-518501, Andhra Pradesh, India.

R. Dharani
Department of Pharmaceutical Analysis, Santhiram College of Pharmacy, Nandyal-518501, Andhra Pradesh, India.

 

K. Raj Kumar
Department of Pharmaceutical Analysis, Santhiram College of Pharmacy, Nandyal-518501, Andhra Pradesh, India.

 

N. Venkateswara Reddy
Department of Pharmaceutical Analysis, Santhiram College of Pharmacy, Nandyal-518501, Andhra Pradesh, India.

 

P. Chandana
Department of Pharmaceutical Analysis, Santhiram College of Pharmacy, Nandyal-518501, Andhra Pradesh, India.

 

V. Ravikumar
Department of Pharmaceutical Biotechnology, School of Pharmacy, Guru Nanak Institutions Technical Campus, Hyderabad, Telangana, India.

 

J. Kumar Raja
Department of Pharmaceutical Analysis, Mother Teresa College of Pharmacy, Kothuru, Sanketika Nagar, Sathupally, Telangana 507303, India.

 

Please See the book here :-  https://doi.org/10.9734/bpi/prrat/v2/563

Bioanalytical Method Development and Validation of Garenoxacin Mesylate in Human Plasma by RP-HPLC and Its Pharmacokinetic Application | Chapter 9 | Advanced Concepts in Pharmaceutical Research Vol. 7

A simple, precise, accurate RP-HPLC method was developed for the estimation of Garenoxacin mesylate in human plasma using Ciprofloxacin Hydrochloride as an internal standard. The chromatographic conditions optimized were Zorbax Eclipse XDB C18 (250 x 4.6 mm, 5µ) column, Mobile phase 0.1% OrthoPhosphoric Acid and Acetonitrile in the ratio of 50:50 (% v/v) with a flow rate of 1.0 ml/min and injection volume of 50 µL. The detection wavelength was set to 240 nm with a column temperature of 30°C. The retention time of Garenoxacin mesylate was found to be 4.0 min. % Coefficient of Variation of Garenoxacin mesylate was found to be 4.30. % Recovery was obtained as 98.97%. The linearity of the proposed method was established in the concentration range of 0.04 to 4 µg/ml (Correlation Coefficient = 0.999). The lower limit of quantification was 0.04 µg/ml which reached the level of a drug possibly found in human plasma. Further, the reported method was validated as per the ICH guidelines and found to be well within the acceptable range. The method was successfully applied to a pharmacokinetic study after oral administration of immediate-release Zinox tablets (200 mg) in healthy Albino rabbits. The mean Cmax was found to be 5540 ng/ml, which occurred at a Tmax of 1.00 hr. The half-life and AUC0-α values were found to be 13.52 hr and 72187 ng. hr/ml. The method was found to be applicable to bioequivalence studies.

Author(s) Details:

A. Ajitha,
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar, Porur, Chennai - 600 116, India.

K. Sujatha,
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar, Porur, Chennai - 600 116, India.

Please see the link here: https://stm.bookpi.org/ACPR-V7/article/view/13733

Recent Development and Validation of Tolperisone HCl and Diclofenac Sodium in Bulk and Pharmaceutical Dosage Forms by Using RP HPLC Method | Chapter 5 | Advanced Concepts in Pharmaceutical Research Vol. 7

 High-performance liquid chromatography is at present one of the most sophisticated tools for analysis. The estimation of Tolperisone HCl and Diclofenac sodium was done by RP-HPLC. Tolperisone is an oral, centrally-acting muscle relaxant.  The Phosphate buffer was pH 3.0 and the mobile phase was optimized consisting of Methanol: Phosphate buffer mixed in the ratio of 70:30% v/ v. Inertsil C18 column C18 (4.6 x 150mm, 5µm) or equivalent chemically bonded to porous silica particles was used as stationary phase. The detection was carried out using a UV detector at 260 nm. The samples are weighed using the Afcoset ER-200A weighing balance. The solutions were chromatographed at a constant flow rate of 0.8 ml/min. the linearity range of Tolperisone HCl and Diclofenac sodium was found to be from 100-500 µg/ml of Tolperisone hcl and 1-5µg/ml of Diclofenac sodium. The linear regression coefficient was not more than 0. 999. The values of % RSD are less than 2% indicating the accuracy and precision of the method. The percentage recovery varies from 98-102% of Tolperisone HCl Diclofenac sodium. LOD and LOQ were found to be within the limit. The results obtained on the validation parameters met ICH and USP requirements.

Author(s) Details:

M. Archana,
School of Pharmaceutical Sciences, Vels Institute of Science, Technology and Advanced Studies, PV Vaithiyalingam Rd., Velan Nagar, Krishnapuram, Pallavaram, Chennai, Tamil Nadu – 600043, India.

M. Sumithra,
School of Pharmaceutical Sciences, Vels Institute of Science, Technology and Advanced Studies, PV Vaithiyalingam Rd., Velan Nagar, Krishnapuram, Pallavaram, Chennai, Tamil Nadu – 600043, India.

Please see the link here: https://stm.bookpi.org/ACPR-V7/article/view/13543

Determination of Related Substances in Lansoprazole Intermediate by Using Stability-indicating HPLC Method | Chapter 9 | Advanced Concepts in Pharmaceutical Research Vol. 6

The present study determines the related substances in lansoprazole intermediate by using stability-indicating HPLC method. Lansoprazole intermediate is the critical raw material for synthesizing the drug substance, lansoprazole. The purity of the lansoprazole intermediate determines the quality of the lansoprazole drug substance with high yield in the synthetic process during the manufacturing. A novel, reversed-phase liquid chromatographic method was developed and validated to determine related substances in the lansoprazole intermediate. The symmetric peak shape was on a C18 stationary phase with the dimensions of 250 mm column length, 4.6 mm as internal diameter, and 5 microns particles with an economical and straightforward mass-compatible mobile phase combination of formic acid/triethylamine and acetonitrile delivered in gradient mode at a flow rate of 1.0 mL/min at 260 nm. The resolution between the lansoprazole intermediate and its impurities in the developed method was more than 2.0, indicating a significant separation. Regression analysis shows a correlation coefficient greater than 0.999 for lansoprazole intermediate and related substances. Lansoprazole Intermediate's detection and quantitation limits and impurities are 0.01% and 0.005%, respectively. This method indicates that the recovery at different levels is 90 to 110% accurate. The test solution was stable in the diluent for 48 hours. The results of forced degradation studies implied that the Lansoprazole Intermediate was sensitive to acid/base hydrolysis and oxidation conditions, and the mass balance was close to 99.5%. This study used the HPLC system Agilent Technologies 1200, a quaternary pump, an autosampler, and a diode array detector. The chromatographic output signal was monitored and processed by Empower software on an Intel Core i5 computer (Dell).

Author(s) Details:

Balaji Nagarajan,
New Jersey Bioscience Centre, 685, North Brunswick, New Jersey, 08902, USA.

Gunasekar Manoharan,
New Jersey Bioscience Centre, 685, North Brunswick, New Jersey, 08902, USA.

Please see the link here: https://stm.bookpi.org/ACPR-V6/article/view/13467

Development and Validation of a Reverse Phase High Performance Liquid Chromatography for Simultaneous Determination of Eprosartan Mesylate and Hydrochlorthiazide in Pharmaceutical Dosage Form | Chapter 13 | Advanced Concepts in Pharmaceutical Research Vol. 3

 The aim of this study search out develop a alone isocratic phase HPLC method for the concurrent determination of Eprosartan mesylate and hydrochlorthiazide . The concurrent detection of hydrochlorthiazide and eprosartan mesylate together has been adept through the development and validation of a plain, fast, sensitive, and exact reverse phase souped up liquid chromatographic (RP-HPLC) method. Two together medications were separated by chromatography utilizing a Purospher BDS C18 column (250 mm × 4.6 mm id, 5µm atom size). The travelling phase involving of acetonitrile :methanol:0.01M KH2PO4 buffer (40:40:10) was brought at a flow rate of 1.0mL/min. The discovery was carried out at 270nm. The overall run period is 5 minutes, and the memory times for Eprosartan mesylate are 3.56 notes of meeting and 4.62 minutes, respectively. The assay for hydrochlorthiazide and eprosartan mesylate is uninterrupted within the aggregation range of 216-576µg/mL and 9-24µg/mL respectively. The judgments of the analysis have happened corroborated by recovery studies. The excipients in the formulations have no effect on the assay arrangement. The suggested approach was used to favorably detect Eprosartan mesylate and hydrochlorthiazide in drug formulations.

Author(s) Details:

Devika G. S.,
Department of Pharmaceutical Analysis, Cherraan’s College of Pharmacy, 521, Siruvani Main Road, Coimbatore-641039, Tamil Nadu, India.

Ramesh Petchi R.,
Department of Pharmacology, Cherraan’s College of Pharmacy, 521, Siruvani Main Road, Coimbatore-641039, Tamil Nadu, India.

M. Sudhakar,
Department of Pharmaceutical Chemistry, Malla Reddy College of Pharmacy, Maissamaguda, Dullapally, Secunderabad -14, India.

J. Venkateshwara Rao,
Department of Pharmaceutical Chemistry, Sultan Ul Uloom College of Pharmacy, Road No3, Banjara Hills Secunderabad- 500034, India.

Please see the link here: https://stm.bookpi.org/ACPR-V3/article/view/12714

The Validation of Cryptographic Algorithms and Development of Block Ciphers with Electronic Code Book for a Control System at Nuclear Power Plants: A Scientific Approach | Chapter 11 | Advances and Challenges in Science and Technology Vol. 9

 This study specifies approaches for validating cryptographic algorithms that should be secondhand continually at the critical control system of I&C in Nuclear Power Plants (NPPs).  The mathematical system has many advantages and mechanics advances in the operation of many energy-producing station systems. However, cybersecurity concede possibility be considered essential for stable movement of digital methods. NPPs have acknowledged the need of nuclear cybersecurity.  Basic operating organizations along with joined systems production organizations, design companies, and supervisory agencies are looking at methods to prepare for basic cybersecurity according to regulatory directions and security-related guidelines issued by supervisory agencies around the globe, including the IAEA, NRC, and KINAC.  To meet nuclear cybersecurity flags, cryptographic algorithms must be developed and redistributed.   Validation programs are created in the PLC, a important component of an NPP's I&C, using the suggested blueprints, and the validation program is confirmed by simulation results. The approaches suggested in this place paper may offer guidance for Cryptographic Piece Validation Shaping for Control Systems in NPPs, as there hasn't happened any work done on evolving a cryptographic algorithm confirmation program for crucial digital methods of NPPs. Specifically, program codes and confirmation models are introduced together with particular testing methodologies for ECB way-based block ciphers between many CMVP.

Author(s) Details:

Jun Young Son,
Security Technology Research Department, Korea Atomic Energy Research Institute, Republic of Korea.

Please see the link here: https://stm.bookpi.org/ACST-V9/article/view/12633

Cross-cultural Validation: Sniffin’ Sticks Olfactory Test for Threshold, Discrimination, and Identification in Spanish-speaking Cohorts | Chapter 4 | Current Innovations in Disease and Health Research Vol. 8

 The amount of olfactory function is more and more pertinent, particularly in cases of intelligent decline, where having fragrance changes might serve as early biomarkers. The Sniffin’ Sticks Olfactory Test, corroborated internationally, offers an objective measure of having fragrance performance. Olfactory testing is involved of three different parts: olfactory threshold, scent discrimination, and scent identification. The Sniffin’ Sticks Olfactory Test is an optimal accomplishment test that evaluates these three components of olfaction to create a composite score resulting from the summary of threshold, discrimination, and labeling. This study sought to legalize the test in a Spanish cohort. The normative sample encompassed 209 healthy normosmic steps forward (154 females, 55 males), old 20 to 79 years (mean age = 50.11 ± 15.18 age). Additionally, 22 participants were retested for test-retest reliability, and scent familiarity in the affecting animate nerve organs identification test was explored in an free healthy sample (n = 69), making necessary cultural transformation. The findings revealed corresponding performance middle from two points genders and smokers/non-smokers across all tests. However, significant intergroup differences arose in scores across age brackets. Notably, having fragrance function exhibited a progressive decline accompanying age, with things over 60 years displaying rude scores. This comprehensive dataset, accompanying culturally tailored adaptations, enables the presidency of the Sniffin’ Sticks Olfactory Test within the Spanish culture. In summary, our study underscores the applicability of the Sniffin’ Sticks Olfactory Test in Spain. This form's validation, accompanying insights into cultural shadings and normative dossier, provides a robust establishment for its exercise, facilitating accurate affecting animate nerve organs assessments in Spanish things across various age groups.

Author(s) Details:

María Luisa Delgado-Losada,
Experimental Psychology, Cognitive Processes and Speech Therapy Department, Faculty of Psychology, Complutense University of Madrid, Campus de Somosaguas, 28223 Pozuelo de Alarcón, Spain.

Alice Helena Delgado-Lima,
Experimental Psychology, Cognitive Processes and Speech Therapy Department, Faculty of Psychology, Complutense University of Madrid, Campus de Somosaguas, 28223 Pozuelo de Alarcón, Spain.

Jaime Bouhaben,
Experimental Psychology, Cognitive Processes and Speech Therapy Department, Faculty of Psychology, Complutense University of Madrid, Campus de Somosaguas, 28223 Pozuelo de Alarcón, Spain.

Please see the link here: https://stm.bookpi.org/CIDHR-V8/article/view/12410

HPLC Methods for the Quantification of Cyproheptadine Hydrochloride, Vitamins Using RP-HPLC with UV Detection | Chapter 6 | Advanced Concepts in Pharmaceutical Research Vol. 2

 For the purposes concerning this investigation, we have forged straightforward RP-HPLC methods for the analysis of cyproheptadine hydrochloride, thiamine mononitrate, calcium pantothenate, and pyridoxine hydrochloride. The International Conference on Harmonization's (ICH) Q2(R1) 2005 tests were followed in the conduct concerning this study. The quality control of various APIs in single dose forms depends massively on the availability of reliable, high-throughput examining technologies. Here, we present the growth and validation of two methods for the identification and calculation of calcium pantothenate, cyproheptadine hydrochloride (CH), thiamine mononitrate (Vit. B1), and pyridoxine hydrochloride (Vit. B6) in uncoated tablets. For the vitamin test, a movable phase combination of phosphate buffer pH 3.5 and flammable liquid in the ratio 93:7 was secondhand. The stationary point used was Eurospher ODS (150 x 4.5mm), and the flow rate was judge 1.0 mL/min (ambient hotness settings). For thiamine mononitrate and pyridoxine hydrochloride, the awareness of detection was 270 nm accompanying a run time of 0.00 to 5.50 summary, and for calcium pantothenate, it was 205 nm with a run occasion of 5.50 to 11.00 minutes. The dose volume was 20 µL. A good judgment, and a short run time of 11 record were achieved accompanying the validated environments. The retention opportunities of thiamine mononitrate, pyridoxine hydrochloride and calcium pantothenate were 2.823 ± 0.020, 4.184 ± 0.007 and 10.025 ± 0.015 minutes individually.The mobile phase arrangement for cyproheptadine HCl was methanol and an ion-making solution (70:30), judge a flow rate of 1.0 mL/min, a runtime of 8 notes of meeting, an injection capacity of 20 µL, and a wavelength of 285 nm utilizing Eurospher ODS (150 x 4.5 mm) as the stationary chapter. The retention opportunity for cyproheptadine HCl was 4.961 ± 0.006.Both methods were raise to be distinguishing, with undeviating dynamic ranges of 0.0192 mg/mL - 0.0288 mg/mL for thiamine mononitrate, 0.0128 - 0.0192 mg/mL for pyridoxine hydrochloride, 0.032 - 0.048 mg/mL for calcium pantothenate and 0.032 - 0.048 mg/mL for cyproheptadine hydrochloride. The equivalence coefficient (R2) for cyproheptadine hydrochloride, thiamine mononitrate, pyridoxine hydrochloride and calcium pantothenate were more 0.999.The purpose of this study was to evolve and validate plain HPLC methods for the belief of cyproheptadine hydrochloride, vitamins B1, B5 and B6 in combined portion of drug or other consumable forms. The proposed means were found expected precise, correct, and robust for the belief of cyproheptadine hydrochloride, vitamins B1, B5 and B6.

Author(s) Details:

Yayra Tuani,
Letap Pharmaceuticals Ltd., P.O. Box GP 3346, Accra, Ghana.

Seth Amo-Koi,
United States Pharmacopeia-Ghana, No. 3 Park Avenue, Motorway Extension, North Dzorwulu, P.O. Box WY 1204, Kwabenya, Accra, Ghana.

David Mingle,
Department of Pharmaceutical Sciences, College of Pharmacy, University of Tennessee Health Science Centre, 881 Madison Ave, Memphis, TN 38163, USA.

Andrew Gordon,
Department of Science Laboratory Technology, Accra Technical University, Accra, Ghana.

Angela Asor,
Department of Chemistry, Michigan State University, 578 S Shaw Lane, East Lansing, MI 48824, USA.

Please see the link here: https://stm.bookpi.org/ACPR-V2/article/view/12338

Comprehensive Analysis of Quality Management in Pharmaceutical Manufacturing Process | Chapter 2 | Advanced Concepts in Pharmaceutical Research Vol. 2

 The objective concerning this topic is to study the limits which are responsible for the status output. The data stresses the importance of quality in the drug industry, defining it as intersection customer needs and expectations. Quality limits include fitness for use, consumer satisfaction, and conformance to requirements. Quality Assurance (QA) focuses on processes, record-keeping and audits, encompassing all determinants affecting product kind, including Good Manufacturing Practices (GMP). Current Good Manufacturing Practice (cGMP) regulations are main to ensuring consistent drug quality and safety. Quality Control (QC) manages daily quality administration, from raw material testing to things produced release, requiring well-trained work force and suitable equipment. Calibration asserts equipment accuracy for trustworthy measurements. Validation ensures processes and orders consistently produce safe and productive products, covering supplies, processes, cleaning, computer systems, strength testing, regulatory agreement, and comprehensive documentation. These ingredients collectively uphold drug quality and regulatory agreement.

Amol S. Deshmukh,
Indrayani Vidya Mandir’s Krihnarao Bhegade Institute of Pharmaceutical Education and Research, Talegaon Dabhade, Pune-410507, India.

Pravin R. Dighe,
S.M.B.T. College of Pharmacy, Dhamangaon, Nashik-422403, India.

Vijay R. Mahajan,
S.M.B.T. College of Pharmacy, Dhamangaon, Nashik-422403, India.

Vikas D. Kunde,
Pravara Rural College of Pharmacy, Chincholi, Nashik-422102, India.

Ganesh S. Mhaske,
Indrayani Vidya Mandir’s Krihnarao Bhegade Institute of Pharmaceutical Education and Research, Talegaon Dabhade, Pune-410507, India.

Shyam S. Awate,
Indrayani Vidya Mandir’s Krihnarao Bhegade Institute of Pharmaceutical Education and Research, Talegaon Dabhade, Pune-410507, India.

Please see the link here: https://stm.bookpi.org/ACPR-V2/article/view/12334

Development and Validation of HPLC Assay Method of Tofisopam by QBD Approach | Chapter 6 | Novel Aspects on Pharmaceutical Research Vol. 8

The aim of the work is to develop and confirm novel, simple, increased reversed phase chromatography form for assay of Tofisopam in pure and pill form. Quality by design (QBD) refers to the achievement of sure predictable character with desired and fixed specifications. The QbD approach stresses product and process understanding with character risk management and controls, happening in higher assurance of crop quality, regulatory elasticity, and continual bettering. The experimental trial was by Box Behnken design using Design Expert® program 10 version. The attributes picked were peak symmetry, NTP and peak purity. The forecasted data compensated with actual exploratory data. The exploratory design suggested the robust MODR domain for the TF HPLC method development. All the approved parameters were inside the acceptable criteria of ICH directions. The optimized chromatographic environments required quaternary send with travelling phase of Water: Acetonitrile 25:75 v/v at 1 ml/min, microwave temperature at 25oC at 310 nm utilizing C18 (250 X 4.6 mm Id, 5μm) column and PDA detector accompanying a run time of 5 brief time period. In this investigation, three independent variables-peak proportion, retention time, and NTP-were used to decide the concentration of the natural phase, oven hotness, and flow rate. The linearity design, precision, accuracy, and precision were all verified. With an overall average veracity of 99.98%, the approach provided linear reactions spanning the aggregation range of 4 to 24 ppm. Regarding the tofisopam retention time, the approach was trustworthy, repeatable, and precise.

Author(s) Details:

Megha Kokane,
Department of Quality Assurance, Shri. D. D. Vispute College of Pharmacy & Research Center, New Panvel, Navi Mumbai-410206, Maharashtra, India.

Jeeja Pananchery,
Department of Pharmacognosy, D. Y. Patil Deemed to be University School of Pharmacy, Nerul, Navi Mumbai-400507, Maharashtra, India.

Monika Jadhav,
Department of Quality Assurance, C. U. Shah College of Pharmacy, SNDT Women’s University, Sir Vithaldas Thakersay, Santacruz West, Juhu, Mumbai-400049, Maharashtra, India.

Ashish Jain,
Shri. D. D. Vispute College of Pharmacy & Research Center, New Panvel, Navi Mumbai-410206, Maharashtra, India.

Please see the link here: https://stm.bookpi.org/NAPR-V8/article/view/11653

Metallothioneins and Their Influence on Bone Metabolism in Patients with Down Syndrome: Application to Dental Implants and Periodontitis | Chapter 11 | Current Progress in Medicine and Medical Research Vol. 6

 In this deoxyribonucleic acid validation study, we destined to verify the results of our first deoxyribonucleic acid expression analysis. Metallothionein’s (MTs) are the lower microscopic weight (6-7 kDa) proteins that are raise to be present in principal part organism types varying from prokaryotes to eukaryotes species. MT are the metal detecting proteins that can diminish the effect caused apiece excess alloy ions. The study was descriptive and practical, and the only invasive procedures acted on patients were the group of a small amount of ancestry and a dental examination.  We acted retrotranscription (RT-qPCR) of 11 RNA-to-cDNA samples using the SuperScript™ VILO™ kit (50; remark 1176605) from Thermo Fisher. We conducted the study utilizing the real-period PCR technique on the q-PCR ViiA 7 floor from Thermo Fisher. We chose the format of the Taqman Array Plate 16 Plus (citation 4413261) from Thermo Fisher, which shelters 12 genes plus four controls (GAPDH, 18S, ACTB, and HPRT1). We conducted the study of the plates using the Thermo Fisher Cloud Web Software. The results of changed MT expression that were first written came from the comparison middle from two points Down’s Syndrome patients accompanying periodontal disease and insert failure (PD+RI+) following in position or time two years of progression against Down’s syndrome sufferers without periodontal affliction and with a beneficial progression of their implants (PD-RI-). The results obtained through deoxyribonucleic acid validation study show that in PD+RI+ patients, the genes encrypting the isoforms MT1F (FD 0.3; p = 0.039), MT1X (FD 338; p = 0.0078), MT1E (FD 307; p = 0.0358), and MT2A (FD 252; p = 0.0428) continue to show downregulation, inasmuch as MT1B (FD 2.75; p = 0.580), MT1H (FD 281; p = 0.152), MT1L (FD 354; p = 0.0965), and MT1G (FD 336; p = 0.0749) no longer show statistically significant results. According to our results, metallotein absorption is related to cartilage metabolism disorders that influence the course of periodontitis and the deficiency of dental implants in subjects with Down syndrome.

Author(s) Details:

Maria Baus-Dominguez,
Department of Dentistry, Faculty of Dentistry, University of Seville, Seville, Spain.

Raquel Gomez-Diaz,
Institute of Biomedicine of Seville, Seville, Spain.

Jose-Luis Gutierrez-Perez,
Oral Surgery Department, Faculty of Dentistry, Oral and Maxillofacial Unit, Virgen del Rocio Hospital, University of Seville, Seville, Spain.

Daniel Torres-Lagares,
Department of Dentistry, Faculty of Dentistry, University of Seville, Seville, Spain.

Guillermo Machuca-Portillo,
Department of Dentistry, Faculty of Dentistry, University of Seville, Seville, Spain.

Maria-Angeles Serrera-Figallo,
Department of Dentistry, Faculty of Dentistry, University of Seville, Seville, Spain.

Please see the link here: https://stm.bookpi.org/CPMMR-V6/article/view/11483

Rapid Determination of Carboplatin and Docetaxel Using RP-HPLC with PDA Detector | Chapter 11 | Novel Aspects on Pharmaceutical Research Vol. 7

 Objective: In the current inquiry, to separated and legalize the cancer healing drugs (Carboplatin and Docetaxel) through the HPLC (e-2695) tool containing a PDA indicator.Methods: A simple, discriminating, validated and well-defined establishment that shows isocratic RP-HPLC methodology for the determinable determination of Carboplatin and Docetaxel. The chromatographic strategy exploited Symmetry C18 column of ranges 150x4.6 mm, 3.5 micron, using isocratic elution accompanying a mobile phase of acetonitrile and 0.1% ortho phosphoric acid (40:60). A flow rate of 1 ml/brief time period and a detector intuitiveness of 225 nm utilizing the PDA indicator were given in the instrumental scenes. Recovery, specificity, extent of object, accuracy, robustness, masculinity were determined as any of method confirmation and the results were found to be inside the acceptable range. Validation of the projected method was completed activity according to an international convention on harmonization (ICH) directions.Results: LOD and LOQ for the two alive ingredients were established concerning test concentration. The measurement charts plotted were linear accompanying a regression cooperative of R2>0.999.Conclusion: The proposed form to be fast, simple, possible and affordable in assay condition. During strength tests, it can be secondhand for routine analysis of production samples and to confirm the quality of drug samples all the while stability studies.

Author(s) Details:

Potturi Rama Devi,
Vidya Jyothi Institute of Technology, Hyderabad, Telangana, India.

Kantipudi Rambabu,
RVR & JC College of Engineering, Chowdavaram, Guntur, AP, India.

Please see the link here: https://stm.bookpi.org/NAPR-V7/article/view/11441

Healthy Apgar, by Caniço and Lopes – A Validation Study | Chapter 10 | Current Innovations in Disease and Health Research Vol. 2

 Aims: Validate the judgment method straightforwardly’ Health "Healthy Apgar by Caniço and Lopes", reinforcing the pertinence of the form in the Person’ study (Personal Realization, Work, Friends, Society, Lifestyles, Morbidities) and Family Health. Understand the importance of the plan for its opportuneness and potentialities in establishing a health management plan.Materials and Methods: A cross-sectional study was completed activity for the consumers of UCSP Dr. Manuel Cunha, over 18 years traditional, using the Apgar Healthy inquiry. The statistical study was based on the explanatory and validation study, that involves the selection of articles, the identification of factorial construction and the validity / dependability study, that was done by factorial study utilizing Cronbach's α.Results: In the sample of 870 respondents, mean age was 48.37 age, with a slight reign of females. In the ending classification of the inquiry 51.6% bestowed a healthy Apgar, 48.2% quite healthy and 0.2% sick. The subscales with the maximal scores were Work and Lifestyle. The Morbidity subgroup presented rude score.Discussion: Validation process observed 112 items of the original inquiry (85% of the total of 132 items), distant 2 complete questions (each with 5 articles) and 8 scattered articles and reshaped two questions.Conclusion: Questionnaire "Healthy Apgar by Caniço and Lopes" is an renewed, suitable and integrative pattern that brings together fundamental components for person’ study and welcome / her care plan. Its validation results in an undisputed advance in Family Medicine.

Author(s) Details:

Hernâni Caniço,
University of Coimbra, Portugal.

Susana Lopes,
UCSP Sertã, Portugal.

Rui Fernandes,
USF Manuel Cunha – Health Center of S. Martinho do Bispo, Coimbra, Portugal.

Ana Cristina Rosa,
Mathematics Department, Faculty of Science and Technology, University of Coimbra, Portugal.

Maria Emília Nogueira,
Mathematics Department, Faculty of Science and Technology, University of Coimbra, Portugal.

Please see the link here: https://stm.bookpi.org/CIDHR-V2/article/view/11198

Classification of Families Types, by Caniço and Fernandes: A Validation Study | Chapter 9 | Recent Trends in Arts and Social Studies Vol. 4

 Aims: Validate the Classification of Families Types, by Caniço and Fernandes, in accordance with overall structure/movement (21), conjugal relationship (6) and paternal relationship (7), projected by Caniço, et al, in procedure "New Types of Family Care Plan”, in which 5 types of offspring are original (pregnant, inbred, diversified, parent-concentrated, and non-objective). Understand its significance, in clinical practice, for creating an individual and offspring care plan adapted to existing families.Materials and Methods: Cross-divided observational study of 1400 UCSP patients of UCSP Dr. Manuel da Cunha, S. Martinho do Bispo Health Center. Data calm by the authors of the study, through conference of the family dispassionate process, interview and application of the inquiry "Healthy Apgar", chapter "Family". Statistical analysis, explanatory and inferential, expanded using IBM SPSS® operating system.Results: All defined family types were recognized, characterized and statistically resulted, with a larger frequency of nuclear offspring (family form / dynamics), accompaniment and modern (matrimonial relationship) and balanced/resistant (parental friendship).Conclusions: The new Classification of Families Types meets validation tests once all family types have existed statistically tested. The present study additional credibility and mathematical reliability to the relationships that were tentatively already acted in the clinical scene. This is endowed accompanying interest in pre/post graduate education and in the clinical practice of Family Physicians, for one demonstrated naturalization to contemporary offspring, their evaluation and creation of individual and classification care plan.

Author(s) Details:

Hernani Canico,
Faculty of Medicine, University of Coimbra, Portugal.

Susana Lopes,
UCSP - Health Center of Sertã, Portugal.

Rui Fernandes,
USF Manuel Cunha – Health Center of S. Martinho do Bispo, Coimbra, Portugal.

Ana Cristina Rosa,
Mathematics Department, Faculty of Science and Technology, University of Coimbra, Portugal.

Maria Emília Nogueiras,
Mathematics Department, Faculty of Science and Technology, University of Coimbra, Portugal.

Please see the link here: https://stm.bookpi.org/RTASS-V4/article/view/11125

Estimation of Metformin Hydrochloride, Gliclazide and Pioglitazone Hydrochloride: A UDDD-HPTLC Densitometry Method Validation Study | Chapter 12 | Novel Aspects on Pharmaceutical Research Vol. 3

 A plain and new UDDD-HPTLC method has happened developed and justified for their estimation of MET, GLZ and PIO all-inclusive and combined dose dosage form. Metformin (MET) is chemically, 1-carbamimidamido-N-N-dimethyl- methanimidamide. It is an oral antagonistic-diabetic drug from the biguanide class. It is the first-line drug for the treatment of type-2 diabetes, specifically in overweight and corpulent people and those accompanying normal sort function and evidences suggest possibly the best choice for people as political whole with heart attack.The  chromatographic  separation  of  these  drugs  was  completed activity  on  precoated  TLC  plates  silica  gel  60F254by  two  mobile steps consisting of Ammonium Sulphate: Methanol: Acetonitrile: Water (4:3:2:1) for MET and PIO and Toluene: Ethyl Acetate: Formic Acid (6:4:0.5) for GLZ individually for ideal separation and good judgment. The densitometric detection and calculation were carried out at 237 nm for MET and 200 nm for GLZ and PIO. The confirmation parameters were rigidly followed as per the ICH directions.Chromatographic separation of the standard answer of MET, GLZ and was performed. Briefly, the spot of the standard answer was applied on TLC plates. The TLC plates were developed by uninterrupted ascending growth by using miscellaneous solvents in the way that acetone, benzene, chloroform, ethyl acetate, intoxicating and toluene. The linearity range was got at 3000-8000ng/spot, 360-960 ng/spot, 90-240 ng/spot for MET, GLZ and PIO with r2value>0.999. The different parameters to a degree precision, reproducibility, strength were efficiently obtained believable. The proposed arrangement was successfully used for simultaneous perseverance of MET, GLZ and PIO in the commercial expression.In simultaneous belief, the different opposition of drugs makes it more burdensome to develop and confirm any chromatographic method. In comparison to HPLC, the submitted UDDD-HPTLC method is novel, less high-priced, simpler, smart, and more flexible. This method can be secondhand for routine quality control study because it authorizes simultaneous guess of all API on a single TLC plate accompanying a single application.

Author(s) Details:

Rajesh Varade,
Pacific University, Udaipur, Rajasthan-313024, India.

Harsha Mishra,
Pacific University, Udaipur, Rajasthan-313024, India and K. J. Somaiya Institute of Engineering and Information Technology, Mumbai, Mh-400022, India.

Please see the link here: https://stm.bookpi.org/NAPR-V3/article/view/10887

Development and Validation of RP- HPLC Method for Simultaneous Determination of Niacin (Extended Release) and Lovastatin in Oral Solid Dosage Form | Chapter 14 | Novel Aspects on Pharmaceutical Research Vol. 1

The present study proposed to develop a novel RP-HPLC Method for the guess of Niacin and Lovastatin in Bulk and spoken solid dosage form. For the concurrent estimation of lovastatin and niacin in a linked dosage form, a simple, accurate, and fast HPLC method has existed created and validated. Chromatographic break-up of the two drugs was acted on a Purospher BDS C8 column (150 mm× 4.6 mm id, 5µm piece size). The travelling phase secondhand was a mixture of 0.1% v/v triethylamine (pH 5.0), holding 20 mM of Ammonium acetate buffer: methanol (30:70% v/v).Detection was acted at 237nm and sharp peaks were obtained for niacin and Lovastatin at memory times of 3.2±0.01 brief time period and.6.4±0.01 min individually. The calibration curve was uninterrupted in the concentration range 100-700µg/ml for niacin 3-18µg/ml for Lovastatin; the correlation coefficients were 0.9991 and 0.9992, individually. According to the International Conference on Harmonization (ICH) Q2 (R1) guidelines, the optimised procedure performed well in agreements of specificity, extent of object, detection and quantitation limits, accuracy, and accuracy. It has been proved that this assay can be used to frequently quantify lovastatin and niacin in medicine dosage form. High portion recovery of drug shows the arrangement is free from inference of excipients present in the expression. The proposed form was found appropriate for simultaneous reasoning of NI and LT can be secondhand for routine quality control of their most drug mixture and their combined portion of drug or other consumable form.

Author(s) Details:

G. S. Devika,
Department of Pharmaceutical Analysis, Cherraans College of Pharmacy, Siruvani Main Road, Coimbatore, Tamil nadu, India.

R. Ramesh Petchi,
Department of Pharmacology, Cherraans College of Pharmacy, Siruvani Main Road, Coimbatore, Tamil nadu, India.

M. Sudhakar,
Department of Pharmaceutical Chemistry, Malla Reddy College of Pharmacy, Maissamaguda, Dullapally, Secunderabad -14, Andrapradesh, India.

J. Venkateshwara Rao,
Department of Pharmaceutical Chemistry, Sultan Ul Uloom College of Pharmacy, Road No 3, Banjara Hills, Secunderabad- 500034, Andra Pradesh, India.


Please see the link here: https://stm.bookpi.org/NAPR-V1/article/view/10429

Method Development and Validation for the Estimation of Bortezomib in Pure and Its Pharmaceutical Tablet Dosage form by UV Spectroscopy | Chapter 13 | Novel Aspects on Pharmaceutical Research Vol. 1

 Background: Bortezomib is an antagonistic-cancer cure used to treat multiple myeloma and mantle container lymphoma.Methods: The UV Spectroscopy method for reasoning of bortezomib was developed and legitimized as per ICH guidelines. The estimation of bortezomib in the clean and tablet portion of drug or other consumable form was carried out at the maximum absorbance at 365 nm.The Results: The order was found to be uninterrupted and obeys stout law in the aggregation range 5-25µg/ml with a correlation cooperative 0.999, the developed means was validated as per ICH directions and was found to be correct and precise.Conclusion: A accelerated novel precise and correct UV Spectroscopy method was grown and validated and can be secondhand for regular study for the estimation of bortezomib.

Author(s) Details:

R. Nageswara Rao,
Department of Pharmaceutical Analysis, Santhiram College of Pharmacy, Nandyal-518501, Andhra Pradesh, India.

V. Ravikumar,
Department of Pharmaceutical Biotechnology, School of Pharmacy, Guru Nanak Institutions Technical Campus , Hyderabad, Telangana, India.

L. Shiva Shankar Reddy,
Department of Pharmaceutical Analysis, Santhiram College of Pharmacy, Nandyal-518501, Andhra Pradesh, India.

D. Madhuri,
Department of Pharmaceutical Analysis, Creative Education Society’s College of Pharmacy, NH-7, Chinnetekur, Kurnool-518218, A. P. India.

N. Yellasubbaiah,
Department of Pharmaceutical Analysis, Santhiram College of Pharmacy, Nandyal-518501, Andhra Pradesh, India.

S. V. Suresh Kumar,
Department of Pharmaceutical Analysis, Santhiram College of Pharmacy, Nandyal-518501, Andhra Pradesh, India.

N. Madana Gopal,
Department of Pharmaceutical Analysis, Santhiram College of Pharmacy, Nandyal-518501, Andhra Pradesh, India.

S. Indradev,
Department of Pharmaceutical Analysis, Creative Education Society’s College of Pharmacy, NH-7, Chinnetekur, Kurnool-518218, A. P. India.

S. Vinay,
Department of Pharmaceutical Analysis, Creative Education Society’s College of Pharmacy, NH-7, Chinnetekur, Kurnool-518218, A. P. India.

S. Mahesh,
Department of Pharmaceutical Analysis, Creative Education Society’s College of Pharmacy, NH-7, Chinnetekur, Kurnool-518218, A. P. India.

P. Ajay Kumar,
Department of Pharmaceutical Analysis, Creative Education Society’s College of Pharmacy, NH-7, Chinnetekur, Kurnool-518218, A. P. India.

Please see the link here: https://stm.bookpi.org/NAPR-V1/article/view/10426