Development And Validation Of RP-HPLC Method For Estimation Of Favipiravir API And It's Tablet Dosage Form Using Quality By Design Approach

Abstract

Favipiravir is a pyrazine carboxamide derivative discovered by Toyama chemical of Japan to act against many RNA viruses ( potent broad spectrum inhibitor of Influenza & other RNA viruses). The present study gives the development of the RP HPLC method by using Quality by Design followed by validation of developed method for estimation co Favipiravir in bulk and tablet dosage form. The central composite method was applied on organic Phase concentration & buffer PH for initial Screening studies. The selection of optimum chromatographic condition was carried out by design space numerical, graphical optimization on retention time, Peak asymmetry & Theoretical Plates. Optimized analytical method consisted Acetonitrile: water (80:20%v/v) as mobile phase, pH 5, flow rate 1ml/min, a wavelength 323 nm. Favipiravir was eluted with retention time 2.7 min & peak area 51248, Favipiravir showed good linear relationship in range of 10-90 µg/ml with a correlation coefficient of 0.9985. The % RSD for intraday, inter day precision & Repeatability was found to be 0.88, 0.65 & 0.97 respectively. Limit of detection & quantification was found to be 104.44 µg/ml &. 316.5 µg/ml. The method validation parameters were in the prescribed limit as per ICH guidelines.