Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF SOFOSBUVIR AND VELPATASVIR IN TABLET

Jaimin P. Patel* and Ankit B. Chaudhary

ABSTRACT

A simple, specific, precise, accurate, rapid and robust stability indicating RP-HPLC method has been developed and subsequently validated for the simultaneous estimation of Sofosbuvir and Velpatasvir in tablet. In Reverse Phase High Performance Liquid Chromatography Method the chromatographic system was equipped with Inertsil ODS C18 column (150mm x 4.6mm, 5μm), as stationary phase and DAD detector set at 270 nm, in conjunction with a mobile phase of 0.05M Potassium Dihydrogen Phosphate buffer (pH- 3.5, adjusted with 1% Orthophosphoric acid) and Acetonitrile in the ratio of 60:40 % v/v at a flow rate of 1.0 ml/min. The described method was linear over a concentration range of 20 - 60 μg/ml and 5 – 15μg/ml for Sofosbuvir and Velpatasvir respectively. The retention time of Sofosbuvir and Velpatasvir were 2.720 min and 4.430 min respectively. The % recoveries of Sofosbuvir and Velpatasvir were found to be 99.605% - 101.034% and 100.519% - 100.651% respectively. Method was statistically validated for accuracy, precision, specificity, LOD, LOQ and robustness according to ICH guidelines. Sofosbuvir and Velpatasvir were subjected to stress condition to check the degradation behaviour of them. Sofosbuvir was found stable in Acid and Oxidative condition. Velpatasvir was found stable in Base and Oxidative condition. Both the drug degraded in Thermal condition. The proposed method enables rapid quantification and simultaneous analysis of both drugs from commercial formulations without any interference of excipients. So, the method can be used for routine analysis of Sofosbuvir and Velpatasvir in tablet dosage form.

Keywords: Sofosbuvir, Velpatasvir, RP-HPLC, Stability indicating, Method Validation.