Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE ESTIMATION OF SOFOSBUVIR BY FORCED DEGRADATION STUDIES

R. M. Nemade*, M. N. Dole and Dr. S. D. Sawant

ABSTRACT

A stability indicating RP-HPLC method was developed and validated for the determination of Sofosbuvir using C18column (250mm x 4.6ID, 5μm) with mobile phase of methanol: water (70:30 v/v) with a flow rate of 0.8 ml/min. The detection was done at 261 nm. The retention time of Sofosbuvir was 4.819 min. Sofosbuvir was subjected to stress conditions including acidic, alkaline, oxidation, photolysis and thermal degradation. The degraded products were well resolved from the pure drug with significantly different retention time values. Linearity was found to be 20-100 μg/ml with significantly high value of correlation coefficient. The method was validated for linearity, accuracy, precision, robustness and recovery. The limits of detection and quantification were 0.44 μg/ml and 1.33μg/ml respectively.

Keywords: Sofosbuvir (SFS), RP-HPLC, Forced degradation, Validation.