Abstract
NOVEL RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF SOFOSBUVIR AND VELPATASVIR IN BULK AND COMBINED TABLET DOSAGE FORMS

Meka Srinivasa Rao* and Dr. K. Rambabu

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 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: Methanol (17:83). The flow rate was 1.5 ml/ minute and ultraviolet detector at 269nm. The average retention time for Sofosbuvir and Velpatasvir found to be 2.169 and 2.799 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 40-120 μg/ml for Sofosbuvir and 10-30μg/ml for Velpatasvir.

Keywords: and Velpatasvir, Isocratic, HPLC, Phenyl, Trifluoroacetic acid, Methanol, and Validation.


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