Development and Validation of a Simple and Reliable UV Spectrophotometric Method for the Simultaneous Estimation of Metformin Hydrochloride and Pravastatin Sodium | Chapter 9 | Pharmaceutical Science: New Insights and Developments Vol. 10

 

Background: Metformin hydrochloride is a drug used in the treatment of type 2 diabetes. It exhibits high aqueous solubility, limited solubility in ethanol, and negligible solubility in organic solvents such as acetone, ether, and chloroform.

 

Aim: A straightforward and reliable ultraviolet (UV) spectrophotometric method was developed and validated for the simultaneous estimation of Metformin Hydrochloride (MH) and Pravastatin Sodium (PS) in their pure forms.

 

Methodology: The proposed method employs an absorbance subtraction approach using UV spectrophotometry. Quantification was carried out by measuring absorbance at two selected wavelengths, 232 nm for Metformin Hydrochloride and 238 nm for Pravastatin Sodium. Method validation was performed in accordance with ICH guidelines, including accuracy studies conducted at three concentration levels (75%, 100%, and 125%), and percentage recovery was calculated for both drugs.

 

Results: The method demonstrated acceptable sensitivity, with limits of detection and quantification determined as 0.481 μg/mL and 0.670 μg/mL for MH, and 1.15 μg/mL and 1.68 μg/mL for PS, respectively. Statistical evaluation of validation parameters confirmed that the method exhibited satisfactory precision, accuracy, and selectivity within the specified limits.

 

Conclusion: The validated UV spectrophotometric method is simple, precise, and accurate, making it suitable for the simultaneous estimation of Metformin Hydrochloride and Pravastatin Sodium. The method can be effectively applied for routine analysis of these drugs in pure form and pharmaceutical dosage formulations.

 

 

Author(s) Details

Ankita Sharma
Shiva Institute of Pharmacy, Bilaspur, H.P., India.

 

Kapil Kumar Verma
Minerva College of Pharmacy, Indora, Kangra, H.P., India.

 

Inder Kumar
Minerva College of Pharmacy, Indora, Kangra, H.P., India.

 

Anju Bala
Chandigarh Group of Colleges Landran, Kharar, Greater Mohali, Punjab, India.

 

Bhumika Thakur
Shiva Institute of Pharmacy, Bilaspur, H.P., India.

 

Vandana Thakur
Abhilashi College of Pharmacy, Nerchowk, Mandi, H.P., India.

 

Please see the book here :- https://doi.org/10.9734/bpi/psnid/v10/7061

Estimation of Ribociclib and Letrozole in Solid Dosage form (Tablet): A Novel Analytical Method | Chapter 9 | Current Overview on Pharmaceutical Science Vol. 9

An attempt was created to develop a plain, rapid, and corroborated method for the concurrent estimation of ribociclib and letrozole together tablet portion of drug or other consumable form.Inhibitors of cyclin D1/CDK4 (Cyclin-dependent kinase 4) [2] and CDK6 (Cyclin-weak kinase 6) [2] are found in Ribociclib, which is retailed by Novartis under the brand names Kisqali and Kryxana. This drug is used to treat some types of feelings cancer. The mixture of aromatase inhibitors and fulvestrant Inhibitors of cyclin D1/CDK4 (Cyclin-dependent kinase 4) and CDK6 (Cyclin-reliant kinase 6) are found in Ribociclib, This drug is used to treat few types of breast malignancy. The combination of aromatase inhibitors and fulvestrant.The chromatographic break-up was carried out on Waters, proportion C18 (150 mm×4.6 mm with 3.5 µm), travelling phase secondhand was a mixture of safeguard and acetonitrile in the ratio of 80:20, accompanying flow rate of 1ml/min and dose volume of 10 µL for the assay. The detection was finished using PDA at 260 nm, accompanying run time of 5 brief time period. The retention opportunity for the drugs ribociclib and letrozole was detected expected 2.648 min and 3.151 brief time period, respectively. The pattern was validated in accordance with ICH guidelines.The extent of object of letrozole and ribociclib was observed expected in the range of 0.50–7.50 and 40.01–600.15, Correlation coefficient (r2) 0.999 and 0.9983, individually. Accuracy for ribociclib and letrozole is carried out by repeatable concentrations of 50%, 100%, and 150. Validation determinants of robustness and masculinity were detected to be in limits.The grown method was plain, rapid, and logical; it can be secondhand for the simultaneous belief of ribociclib and letrozole tablet portion of drug or other consumable form in routine analysis. The approved method maybe used for the routine reasoning of both the drugs from size and different formulations and will help in healing drug monitoring (TDM) and bioavailability studies.

Author(s) Details:

Bhagyalata Satapathy,
The Tamil Nadu Dr. M.G.R Medical University, India.

Chaitanya Bangari,
The Tamil Nadu Dr. M.G.R Medical University, India.

Please see the link here: https://stm.bookpi.org/COPS-V9/article/view/10178

Development of RP-HPLC Method for Simultaneous Estimation of Atrovastatin and Ezetimibe in Pharmaceutical Formulation | Chapter 10 | Technological Innovation in Pharmaceutical Research Vol. 3

 A reverse phase HPLC method for simultaneous measurement of Atrovastatin and Ezetimibe from pharmaceutical dosage forms has been developed. It is simple, selective, quick, exact, and cost-effective. At a flow rate of 1 ml/min, the procedure was performed on a Phenomenex C18 (25 cm x 4.6 mm i.d., 5 ) column with a mobile phase of Water and 0.4 percent (v/v) TEA: Acetonitrile (adjusted to pH 6.5 using Orthophosphoric acid) (60:40 v/v). At a wavelength of 248 nm, the detection was performed. Pioglitazone was utilized as an internal control. Retention times for atrovastatin, ezetimibe, and pioglitazone were 3.42, 6.90, and 4.28 minutes, respectively. The established method's accuracy, precision, linearity, limit of detection, limit of quantitation, and solution stability have all been validated. The proposed approach can be used to estimate these medications' dose forms in combination dose forms. Raw materials, formulations, and dissolution tests can all be checked using the current RP-HPLC technology.

Author (s) Details

S. Alexandar
Department of Pharmaceutical chemistry, Vinayaka Mission’s College of Pharmacy, Vinayaka Missions Research Foundation (Deemed to be University),Yercaud Main Road, Salem – 636008, India.

View Book :- https://stm.bookpi.org/TIPR-V3/article/view/1153