Validated Stability Indicating RP-HPLC method for estimation of antiviral class of drugs Sofosbuvir and Velpatasvir in combination and its comparison with reported methods

Abstract

A simple, specific, accurate and stability-indicating reverse phase high performance liquid chromatographic method was developed for simultaneous determination of Sofosbuvir and Velpatasvir, using a BDS C8 (150 x 4.6 mm, 5 μm) column and a mobile phase composed of Buffer (0.1% OPA): Acetonitrile (50: 50, v/v).The retention time of Sofosbuvir and Velpatasvir was found to be 2.267 mins and 2.983 mins respectively when compared with the developed methods the retention time was very less. Linearity was established in the range of 100–600 μg/ml and 25–150 μg/ml for Sofosbuvir and Velpatasvir respectively. The percentage recoveries of Sofosbuvir and Velpatasvir were found to be 100.34% and 101.37% respectively. The drugs were subjected to acid, alkali, hydrolysis, oxidation, dry heat, photolytic and UV degradation and showed very less degradation where no method has reported about the degradation data. The developed method can be successfully employed for simultaneous quantitative analysis of Sofosbuvir and Velpatasvir in bulk and formulations. When the validation parameters of the method developed are compared with those of the earlier reported methods. The developed method was found to be superior in the aspects such as retention time, system suitability and the method was more economical when compared to others as the run time is only 5 minutes.