QbD Approach to Stability Indicating HPLC Method for Estimation of Elbasvir and Grazoprevir by Green Assessment Method | Chapter 4 | Pharmaceutical Science: New Insights and Developments Vol. 2

Introduction: Green chemistry is widely used in worldwide manufacturing, government policy, educational practice, and technology development. The main purpose of the circular economy is to establish a balance between economic growth, resource sustainability, and environmental protection. The global need to adapt procedures to meet the objectives of green analytical chemistry (GAC) is a serious challenge for the pharmaceutical industry. High-performance liquid chromatography (HPLC), one of the techniques used most commonly at various stages in the pharmaceutical industry, generates a massive volume of organic hazardous waste.

Aim: To develop analytical quality by design-aided stability indicating green high-performance liquid chromatography (HPLC) method for estimation of Elbasvir and Grazoprevir in a dosage form.

Materials and Methods: The percentage of ethanol in the mobile phase, flow rate, and their overall impact on the responses, such as asymmetry, theoretical plates, and resolution, were the crucial chromatographic elements that were examined in order to optimise the procedure. The primary goal of green analytical chemistry (GAC) has been to provide environmentally safe analytical techniques. Consequently, the application of GAC principles in pharmacological analysis is essential. A rotatable central composite design was used, and the Zorbax C18 column (4.6 x 150 mm, 5 µm) with 0.1% Trifluoroacetic acid and ethanol (40:60 v/v) as components of a mobile phase flowing at a rate of 1.0 ml/minute was used to create the ideal conditions for chromatographic separation with a run time of 5 minutes. At 253 nm, photodiode array detection was performed.

Results: The retention times for EBS and GZP were 1.8 and 2.84 minutes, respectively. According to ICH recommendations, the proposed approach was validated, and stress tests demonstrated that Elbasvir and Grazoprevir are sensitive to acidic, basic, and oxidative stress conditions. An analytical eco-scale score evaluated the greenness profile, while a software-based evaluation.

Conclusion: The developed HPLC method is eco-friendly and shall be adopted in the routine quality control of Elbasvir and Grazoprevir in a tablet dosage form. The implementation of the green strategies in the pharma analysis will provide benefits for the analysts' healthier working environment, this technique will also help commercial and industrial lab research and testing departments adopt and evaluate the various combinations in bulk and dosage forms.

 

Author (s) Details

 

Charushila Bhangale
Department of Pharmaceutical Chemistry, Pravara Rural Education Society, College of Pharmacy for Women, Chincholi, Nashik, Maharashtra, India.

 

Sachin Somwanshi
Department of Pharmaceutical Chemistry, Pravara Rural Education Society, College of Pharmacy for Women, Chincholi, Nashik, Maharashtra, India.

 

Kiran Kotade
Department of Pharmaceutical Chemistry, Pravara Rural Education Society, College of Pharmacy for Women, Chincholi, Nashik, Maharashtra, India.

 

Mayur Gaikar
Department of Pharmaceutical Chemistry, Pravara Rural Education Society, College of Pharmacy for Women, Chincholi, Nashik, Maharashtra, India.

 

Please see the book here:-https://doi.org/10.9734/bpi/psnid/v2/4074  

 

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