A New Simple Stability-Indicating RP-HPLC- PDA Method for Simultaneous Estimation of Triplicate Mixture of Sofosbuvir, Velpatasvir and Voxilaprevir in Tablet Dosage Form

摘要

A simple, rapid, selective, economical, accurate, reverse phase high performance liquid chromatography (RP-HPLC) was developed for simultaneous estimation of sofosbuvir, velpatasvir and voxilaprevir in its tablet dosage form. The separation was accomplished by means of a mobile phase of buffer and acetonitrile in the ratio of 50:50 pumped at a flow rate of 1 ml/min along with 220 nm as a UV detection wavelength. The stationary phase used was column Waters C18 250 x 4.6 mm, 5m. P. Sofosbuvir, velpatasvir and voxilaprevir were eluted at a retention times were 2.091 for sofosbuvir, 2.640 for velpatasvir and 3.349 mm for voxilaprevir. Analytical method of the proposed RP-HPLC procedure was statistically validated with as per ICH guidelines by considering the parameters such as, system suitability, linearity ranges, precision, accuracy, specificity, and robustness, limit of detection and limit of quantification. The concentration ranges for linearity were 100-600, 25-150 and 25-150 ppm for sofosbuvir, velpatasvir and voxilaprevir respectively with correlation coefficients >0.999. The three drug samples were undergone degradation conditions of acidic and alkaline hydrolysis, oxidation, and photolysis, neutral and thermal degradation. The designed method proved to be stability-indicating by resolution of the analytes from their forced-degradation products. The developed RP-HPLC method can be used for routine analysis of sofosbuvir, velpatasvir and voxilaprevir in combinational dosage form. The planned method finished by PDA as a tool for peak detection and purity confirmation.