ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF SOFOSBUVIR AND VELPATASVIR DRUG PRODUCT BY RP-HPLC METHOD
Journal Title: Indo American Journal of Pharmaceutical Research - Year 2017, Vol 7, Issue
Abstract
Abstract A novel reversed phase high performance liquid chromatography (RP-HPLC) method has been developed for the estimation of Sofosbuvir and Velpatasvir drug product 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: Methanol (42:58). The flow rate was 1.0 ml/ minute and ultra violet detector at 269nm. The average retention time for Sofosbuvir and Velpatasvir found to be 3.44 and 4.68 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 20-60μg/ml for Velpatasvir.
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