Development and Validation of an ICH-Compliant Optimized RP-HPLC Method for Quantitative Analysis of Favipiravir

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.