Abstract

A simple, accurate and precise stability indicating RP-HPLC method was developed for the simultaneous estimation of the Sofosbuvir and Velpatasvir in tablet dosage form. Chromatogram was run through Discovery C18 (250 x 4.6 mm, 5m) column. Mobile phase containing buffer 0.1% OPA: acetonitrile taken in the ratio 50:50 v/v was pumped through column at a flow rate of 1 ml/min. Temperature was maintained at 30°C. Optimized wavelength selected was 240 nm. The method was linear over the concentration range for Sofosbuvir is 100-600μg/ml and for Velpatasvir is 25-150μg/ml. The retention times of Sofosbuvir and Velpatasvir were found to 2.473 min and 3.316 min respectively. %RSD of the Sofosbuvir and Velpatasvir were found to be 0.2 and 0.3 for system precision, 0.4 and 0.5 for repeatability and 0.2 and 0.3 for intermediate precision respectively. %Recovery was obtained as 99.32% and 100.43% for Sofosbuvir and Velpatasvir respectively. LOD and LOQ values obtained from regression equations of Sofosbuvir and Velpatasvir were 0.44, 1.32 and 0.33, 1.01 respectively. Regression equation of Sofosbuvir is y=10179x+3201 and y=16944x+13228 for Velpatasvir respectively. The method was validated and was successfully employed for the routine quantitative analysis of pharmaceutical formulations containing Sofosbuvir and Velpatasvir in combined tablet dosage form.