Estimation of Sofosbuvir with Validated Ultra High Performance Liquid Chromatographic (UHPLC) Method in its bulk and Formulations

In this work, a stability indicating and validated UPLC method has been developed for estimation of Sofosbuvir (API) in bulk and its formulations (Sovaldi？). The chromatographic separation was achieved on a Waters BEH C18 column (2.1 × 100 mm, 1.7 μm) in an isocratic elution mode with flow rate 0.4 mL/min, the mobile phase of Acetonitrile and Water (30:70) in 0.1% formic acid (pH ~2-3). The optimized method is linear over the concentration range of 20-120 ppm; the Limit of Quantification (LOQ) and Limit of detection are 0.063 and 0.03 μg/mL respectively.