Green UHPLC Method development for Quantification of Sofosbuvir and Velpatasvir in bulk and Pharmaceutical dosage form by stability study

Abstract

A straightforward, accurate stability-indicating green UHPLC technique for the simultaneous measurement of sofobusvir and velpatasvir in mixed formulation was developed and verified in accordance with ICH recommendations. A UHPLC-3000 system from Analytical Technologies was used to obtain the separation. The ratio of ethanol to orthophosphoric acid in the mobile phase was 70:30 (V/V), with a flow rate of 1 mL/min kept at room temperature. Sofobusvir and Velpatasvir had retention times of 2.23 min. and 4.34 min., respectively. Utilising UV detection at 260 nm, quantification was accomplished.The dosage form was subjected to photolytic stress, dry heat, alkali, oxidative stress, acid.Drugs and degradation products were clearly distinguished by the procedures.. The created method's greenness has been evaluated by using various  methodologies (including NEMI, GAPI,AES and AGREE)   .The results reveal a score of nine out of fifteen green pictograms for GAPI, four green portions in NEMI, a score of 91 for AES  and a score of 0.89 for AGREE that shows the created approach is completely eco-friendly and adaptable as a sustainable method..