New Analytical Method Development and Validation for Simultaneous Estimation of Sofosbuvir and Velpatasvir in Bulk and Pharmaceutical Dosage Form by RP-HPLC Method
A simple, specific and accurate reverse phase high performance liquid chromatographic method was developed for the simultaneous determination Sofosbuvir and Velpatasvirin pharmaceutical dosage form. The column used was Kromosil C18(150mm x 4.6 mm, 5mm)in isocratic mode, with mobile phase containing phosphate buffer andacetonitrile(70:30v/v). The buffer is prepared by adding 1.41gm of sodium dihyrogen ortho phosphate in a 1000ml of volumetric flask add about 900ml of milli-Q water added and degas to sonicate and finally make up the volume with water then pH adjusted to 3.5 with dil. orthophosphoric acid solution. The flow rate was 1.0ml/ min and effluents were monitored at 260 nm. The retention times of Sofosbuvir and Velpatasvirwere found to be 2.404min and 2.986 min, respectively. The linearity for Sofosbuvir and Velpatasvirwere in the range of 40-240µg/ml and 10-60 µg/ml respectively. The recoveries of Sofosbuvir and Velpatasvirwere found to be 99.64% and 99.25%, respectively. The proposed method was validated and successfully applied to the estimation of Sofosbuvir and Velpatasvirin combined tablet dosage forms.
Keywords: Sofosbuvir, Velpatasvir, Validation, Buffer and ICH Guidelines.
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