ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF SOFOSBUVIR IN BULK AND FORMULATION

Abstract

A Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method was developed and validated for the
estimation of Sofosbuvir which is a new antiviral drug. The RP-HPLC was succeeded on a Phenomenex Luna® LC C18
column (150×4.6mm, 5μm). The mobile phase was effective according to the polarity of studied drug. The mobile phase
was consisting of Acetonitrile: Methanol: Water in the ratio of 50:30:20 v/v/v using at flow rate of 1ml/min. with
injection volume of 20 μL was selected for this present work. Detection was made by using UV detector at 260nm.
Retention time was found to be 2.1min. The developed method was validated according to the ICH guidelines. The
calibration curve was linear for Sofosbuvir in the concentration range of 10-50 μg/ml was good. The developed method
was validated for Linearity, Precision, Accuracy and Robustness of Sofosbuvir drug and was accurate, precise and reliable
for the analysis of Sofosbuvir in formulation. The Relative Standard Deviation for all the parameters were found to be
less than 2 which shows the validated method and results obtained by this method is with fair agreement. Hence, this
developed method can be easily effortlessly adopted for routine analysis for Sofosbuvir in bulk and formulation.