ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF SOFOSBUVIR AND DACLATASVIR DRUG PRODUCT BY RP-HPLC METHOD

Analytical method was developed for the estimation of Sofosbuvir and Daclatasvir drug substance by liquid chromatography. The chromatographic separation was achieved on C18 column (XTerra RP18 150*4.6, 5um) at ambient temperature .The separation achieved employing a mobile phase consists of 0.1%v/v Trifluoro acetic acid in water: Acetonitrile (60:40). The flow rate was 1.0 ml/ minute and ultra violet detector at 275nm. The average retention time for Sofosbuvir and Daclatasvir found to be 2.09 and 3.50 min. The proposed method was validated for selectivity, precision, linearity and accuracy. All validation parameters were within the acceptable range. The assay methods were found to be linear from 80-240 μg/ml for Sofosbuvir and 12-36μg/ml for Daclatasvir