STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS DETERMINATION OF SOFOSBUVIR AND DACLATASVIR IN TABLET DOSAGE FORM

Abstract

New stability indicating RP-HPLC method for the simultaneous estimation of sofosbuvir and daclatasvir in its pharmaceutical dosage form was developed and validated. Column used was PhenomenexC18 (150mm x 4.6mm, 5µ) with mobile phase water and acetonitrile (50:50 V/V) in isocratic mode. Flow rate of mobile phase 1.0mL min-1 and column oven temperature were maintained at 30o C. Sofosbuvir and daclatasvir were detected at a wavelength 230nm. The retention times for sofosbuvir and daclatasvir were found to be 3.06 min and 4.76 min, respectively. Validation of the method was done according to ICH guidelines. The method was found to be accurate, precise, specific and robust. The method shows good linearity in concentration range of 50 µg mL-1 – 500 µg mL-1 of sofosbuvir and 7.5 µg mL-1 – 75 µg mL-1 of daclatasvir, with correlation coefficient of 0.999 for both the drugs. The drugs as well as their degradation products produced in stress study were separated using this developed method.