A New, Rapid, Cost-Effective, Easy and Validated RP-HPLC Method for Determination of Antiviral (Sofosbuvir) in Bulk Forms

Abstract

A simple, specific, accurate and economic reverse phase liquid chromatographic method was developed for the estimation of Sofosbuvir in all polymorphic form. Mobile phase contain acetonitrile and 0.05M ammonium acetate (pH 7.6) in ratio of 50:50 (v/v). A logarithmic calibration curve was plotted from 10 µg/mL to 60 µg/mL (r = 0.9989) for sofosbuvir, with the limit of detection (LOD) and the limit of quantification (LOQ) of 0.245 μg/mL and 0.816 μg/mL, respectively. The developed method was highly validated and practiced for the assurance of sofosbuvir raw materials with acceptable and non-objectionable accuracy and precision results (recovery 99–102%, RSD <1.2%, n = 3). Zero significant difference (t-test) was obtained between the overall results of the developed RP-HPLC method.

Keywords

• Calibration
• Chromatography
• Developed
• Accuracy