STABILITY INDICATING HPLC METHOD FOR SOFOSBUVIR AND DACLATASVIR IN COMBINATION

Abstract

Direct acting fixed dose combination of sofosbuvir and daclatasvir to treat the viral hepatitis C disease is available in the market. So, a precise and robust stability indicating HPLC method for sofosbuvir and daclatasvir was developed. The SunQ C18 column (250 x 4.6 mm) was used for chromatographic separation with mobile phase consisting of 0.03 mM potassium dihydrogen phosphate buffer (pH 7): ACN (50: 50V/V). Optimised method satisfies the system suitability parameters with good resolution with 4.9 min Rt of sofosbuvir and 7.6 min Rt of daclatasvir. The method was validated as per ICH guidelines. Linearity was observed over range of 10-50 (µg mL-1) and 2.25-11.25 (µg mL-1) for sofosbuvir and daclatasvir, respectively. Both drugs were subjected to various stress conditions and high recovery values were found for daclatasvir on photolytic stress. The degradation was more on oxidative and hydrolytic stress for sofosbuvir. This optimised method offers new insight towards stability studies of both drugs.