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

Dr. M. Manoranjani*

ABSTRACT

The aim of the method was to develop and validate a rapid, sensitive and accurate method for simultaneous estimation of Daclatasvir and Sofosbuvir in drug product by liquid chromatography. The chromatographic separation was achieved on Phenyl column (Eclipse XDB-Phenyl 250*4.6, 5um) at ambient temperature.The separation achieved employing a mobile phase consists of 0.1%v/v Trifluoroacetic acid in water: Acetonitrile (50:50). The flow rate was 1.0ml/ minute and ultraviolet detector at 275nm. The average retention time for Daclatasvir and Sofosbuvir found to be 2.805 min and 3.734 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 -240.0μg/mL of Sofosbuvir.

Keywords: Daclatasvir, Sofosbuvir, Isocratic, HPLC, Phenyl, Trifluoroacetic acid, Acetonitrile, Methanol, and validation.


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