A Box-Behnken design optimization based ecofriendly RP-HPLC method For Estimation of sofosbuvir And velpatasvir - Application to stability indicating assay

Abstract

Abstract In this study, a novel, cost effective, accurate, and ecofriendly stability-indicating RP-HPLC technique was developed and validated for the simultaneous measurement of sofosbuvir (SOF) and velpatasvir (VEL) in tablet dosage form. Box-Behnken design was used for multivariate optimization of the experimental parameters of RP-HPLC. The molarity of heptane sulfonic acid sodium salt (HSA), volume of ethanol, and volume of acetonitrile were used to develop mathematical models and study the effects of these factors on various responses. Heptane sulfonic acid sodium (1mM) : acetonitrile : ethanol (80 : 11 : 9 v/v) as the mobile phase, made up the optimal and expected condition. The SOF and VEL retention times were found to be 5.505 and 3.472 minutes, respectively. System suitability, specificity, accuracy, linearity, precision, and solution stability were all considered in the method's validation. For SOF and VEL, linearity was shown across the concentration range of 20–100 µg/ml and 5–25 µg/ml, respectively with correlation coefficient (R2) > 0.999. Studies on forced degradation under acid, basic, oxidative, photolytic, and thermal conditions revealed the drug's well-resolved peak and the degradation products' peaks as well. For the simultaneous determination of sofosbuvir and velpatasvir in conventional laboratory analysis, this newly suggested approach is one that is quick, reliable, and cost-effective. Furthermore, the greenness was analyzed utilizing four cutting-edge metrics, including GAPI, AES, AMGS, and AGREE, and the greenest findings were determined.