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Abstract

DEVELOPMENT AND VALIDATION FOR ESTIMATION OF SOFOSBUVIR IN BULK AND PHARMACEUTICAL DOSAGE

Chennoju Vasudha*, Kunchanapalli Priyanka and Sujan Bathula

 

ABSTRACT

A rapid and precise Reverse Phase High Performance Liquid Chromatographic method has been developed for the validated of Sofosbuvir, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Hypersil C18(4.6×150mm, 5μ) column using a mixture of phosphate Buffer and Acetonitrile (45:55 v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 260nm. The retention time of the Sofosbuvir was 3.166±0.02minrespectively. The method produce linear responses in the concentration range of 35-420μg/ml of Sofosbuvir. The method precision for the determination of assay was below2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.

Keywords: Sofosbuvir, RP-HPLC, validation.


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