DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF DACLATASVIR AND SOFOSBUVIR IN DRUG PRODUCT BY RP-HPLC
Journal Title: Indo American Journal of Pharmaceutical Research - Year 2018, Vol 8, Issue
Abstract
New Analytical method was developed for the estimation of Daclatasvir and Sofosbuvir in drug product by liquid chromatography. The chromatographic separation was achieved on C18 column (Phenyl XDB 250*4.6mm) at ambient temperature .The separation achieved employing a mobile phase consists of 0.1%v/v Trifluoro acetic acid in water : Acetonitrile(500:500). The flow rate was 1.0ml/ minute and ultra violet detector at 275nm. The average retention time for Daclatasvir and Sofosbuvir found to be 2.805 min and 3.743 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 12.0 – 36.0μg/ml for Daclatasvir and 80.0 – 240.0 μg/ml of Sofosbuvir.
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- EP ID EP490243
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