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

A simple, specific, accurate and economic reverse phase liquid chromatographic method was developed for the estimation of Sofosbuvir in all polymorphic form. Mobile phase contains acetonitrile and 0.05M ammonium acetate (pH 7.6) in ratio of 50:50 (v/v). A logarithmic calibration curve was plotted from 10 µgmL-1 to 60 µgmL-1 (r = 0.9989) for sofosbuvir, with the limit of detection (LOD) and the limit of quantification (LOQ) of 0.245 µgmL-1 and 0.816 µgmL-1, 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. [ABSTRACT FROM AUTHOR]