A quantitative RP-HPLC method development and validation for sofosbuvir in bulk and tablet dosage form

Abstract

A new isocratic simple and rapid reverse phase high performance liquid chromatographic method was developed and successively validated for the estimation of Sofosbuvir. In this newly developed method, chromatographic separation of Sofosbuvir was achieved on a Phenomenex C18- column (250 × 4.6) mm within a short runtime of 6 min using mobile phase containing 0.1% Formic acid in water (pH at 2.3) and Acetonitrile in the ratio of 50:50% v/v. Sofosbuvir was estimated with UV detection at 262 nm and it was found to be eluted at 2.983 min. The above mentioned method was validated as per International Conference on Harmonization (ICH) guidelines with respect to accuracy, precision, linearity, limit of detection (LOD) and limit of quantitation (LOQ) and robustness. The method was found specific for Sofosbuvir and linear (r2 =0.9994) over concentrations ranging from 20 to 100 μg/mL. The method was found statically accurate (mean recovery = 99.46%), precise with both intra-day and inter-day relative standard deviation (RSD) values < 1.0% and robust. The obtained results concluded that the proposed RP-HPLC method is convenient, reliable and useful in routine analysis for estimation of Sofosbuvir in its bulk form and dosage form.