Development and validation of RP HPLC method for the estimation of Sofosbuvir and related impurity in bulk and pharmaceutical dosage form

Abstract Background The present work is aimed at development and validation of RP HPLC method which simple, specific, precise, accurate for estimation Sofosbuvir its process-related impurity in bulk pharmaceutical dosage forms. Extensive literature survey revealed no the above said. chromatographic separation was achieved on Agilent Eclipse XDB-C18, 4.6 × 250 mm, 5 μm with mobile phase composed 0.1% trifluoroacetic acid 1000 ml water:acetonitrile (50:50) using an isocratic mode elution. Detection made UV detector 260.0 nm LC solution software analysis data. developed validated according to ICH guidelines. Results linearity calibration curve concentration range 160-480 μg/ml good. linear process related (Phosphoryl) 10-30 μg/ml. There exists a good correlation between peak area analyte concentration. Retention time found be 3.674 min 5.704 min. Relative standard deviation values 1.741 0.043. LOD 0.01% (0.04 μg) 0.03% (0.12 respectively. LOQ 0.50% (0.125 1.50% (0.375 Conclusion All results reveal that proposed highly sensitive, accurate, robust, fast. Large number samples can analyzed shorter due retention times, so it successfully applied routine phosphoryl