Abstract
A NOVEL METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD AND STRESS DEGRADATION STUDY OF DETERMINATION OF SOFOSBUVIR AND VELPATASVIR IN BULK AND COMBINED TABLET DOSAGE FORM

M. Madan Mohan Reddy*, D. Gowri Sankar and J. V. L. N. Seshagiri Rao

ABSTRACT

A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Velpatasvir and Sofosbuvir, in its pure form as well as in tablet dosage form. Chromatography was carried out on a spursil C18 (4.6 x 150mm, 5μm) column using a mixture of Acetonitrile: phosphate Buffer (pH 3.0) (50:50% v/v) as the mobile phase at a flow rate of 1.0mL/min, the detection was carried out at 255nm. The retention time of the Velpatasvir and Sofosbuvir was 3.472, 5.505min respectively. The method produce linear responses in the concentration range of 50-250μg/ml for Velpatasvir, and 200-1000μg/ml of Sofosbuvir. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.

Keywords: Velpatasvir and Sofosbuvir; RP-HPLC; UV Detection; validation.


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