Development and Validation of an ICH-Compliant Optimized RP-HPLC Method for Quantitative Analysis of Favipiravir
Journal Title: International Journal of Experimental Research and Review - Year 2024, Vol 42, Issue 6
Abstract
Favipiravir (FAV) has emerged as a promising antiviral agent. It is particularly effective against influenza and other RNA virus infections. The aim and objective of the present study was developing and optimizing chromatographic conditions for faster analysis of FAV and demonstrating its applicability for tablet assay. The chromatographic separation was obtained using mobile phase with 90:10 % v/v ratio of ammonium acetate buffer (pH 4.5) and methanol on a Waters C18 column (250 x 4.6 mm, 5 µ). A flow rate of 1.4 mL/min was optimized. Chromatographic detection was perform at a wavelength of 323 nm. The FAV retention time was 6.46 min, indicating the efficiency and speed of the method. The developed method was rigorously validated according to ICH guidelines. A strong linear correlation (r2 = 0.9995) was established in the 5–60 μg/mL range, indicating adequacy for quantitative analysis. The method demonstrated high accuracy, with FAV recovery ranging from 98.77 % to 100.89 %. The % RSD results of less than 2% for intermediate precision and repeatability showed that the method exhibited high precision. The developed HPLC method reduces the Rt. Notably, this method complies with regulatory standards, establishing it as a valuable tool for quality assurance, pharmacological evaluation, and clinical monitoring of FAV. Thus, this validated RP-HPLC method provides a robust and sensitive method for routine FAV quantification, with high accuracy, precision, and compliance results, supporting its potential use in the clinical pharmaceutical industry.
Authors and Affiliations
Girija Balasaheb Bhavar, Kiran Balasaheb Aher, Rushikesh Manoj Saindane, Zaid Shaikh, Ketan Vijay Sabale, Jugal D. Mandan
Keywords
Related Articles
- EP ID EP743865
- DOI 10.52756/ijerr.2024.v42.021
- Views 26
- Downloads 0
Anonymity in decentralized apps: Study of implications for cybercrime investigations
In the digital age, cybercrime facilitated by anonymous communication apps raises significant concerns. Criminals exploit the anonymity provided by these apps, creating challenges for law enforcement and cybersecurity pr...
Energetics and Economics of Rabi Maize as Influenced by Smart Nutrient Management Under South Odisha Conditions
Cereal crop cultivation is one of the essential agricultural practices adopted worldwide to feed human beings, providing dietary energy and food security. Maize is important in different cereal crops' areas, production,...
Pneumonia Detection through Deep Learning: A Comparative Exploration of Classification and Segmentation Strategies
The Convolution Neural Network (CNN) algorithm is one of the most widely used methods for identifying and categorizing lung cancer. This paper covers the most suitable architecture and CNN algorithms for lung cancer and...
Efficacy and Safety of Muscle Rub Ointment in The Management of Arthritis and Certain Musculoskeletal Disorders
Traditional Indian medicine has long used Muscle Rub Ointment to treat rheumatoid arthritis (RA), but its safety and effectiveness have not been well studied. To bridge this gap, an extensive investigation was carried ou...
Analysis of Land Use and Land Cover Change Detection for Indore District of Malwa Plateau Region Using Supervised Machine Learning
The main aim of this work is to find out LULC classes for the Indore region. For the last seven years, Indore has been crowned the cleanest city in India according to the latest ranking of 2023. In the Indian state of Ma...