Validated Method development for estimation of Sofosbuvir and Daclatasvir in bulk and their dosage form by using RP-HPLC

Abstract

A simple, Accurate, precise method was developed for the simultaneous estimation of the Sofosbuvir and Daclatasvir in Tablet dosage form. Chromatogram was run through Standard Ascentis C18 150 x 4.6mm, 5m. Mobile phase containing Acetonitrile: Water taken in the ratio 60:40 was pumped through column at a flow rate of 0.7ml/min. Temperature was maintained at 30°C. Optimized wavelength selected was 279nm. Retention time of Sofosbuvir and Daclatasvir were found to be 2.198 min and 2.765 min. %RSD of the Sofosbuvir and Daclatasvir were and found to be 0.4 and 0.3 respectively. %Recovery was obtained as 99.88% and 99.80% for Sofosbuvir and Daclatasvir respectively. LOD, LOQ values obtained from regression equations of Sofosbuvir and Daclatasvir were 1.73, 5.23 and 0.12, 0.36 respectively. Regression equation of Sofosbuvir is y = 9010x+ 21702, and y = 10136x+1757 of Daclatasvir Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.