BIO-ANALYTICAL METHOD DEVELOPMENT AN VALIDATION FOR SIMULTANEOUS DETERMINATION OF SOFOSBUVIR AND LEDIPASVIR IN HUMAN PLASMA IN BULK FORM BY RP-HPLC

Abstract

For the quantification of Sofosbuvir and Ledipasvir in human plasma, A new Reverse Phase High Performance
Liquid chromatographic method was developed. A two step simple liquid-liquid extraction (LLE) procedure was
carried out for the extraction of Sofosbuvir and Ledipasvir from plasma samples.The developed method resulted
in retention times of sofosbuvir and Ledipasvir were found out to be 2.9 and 6.3 min respectively. According to
the ICH guidelines, the method was validated with respect to specificity, precision, accuracy and linearity and
stability studies. The proposed method was found to be reproducible and convenient for the quantitative
analysis of Ledipasvir and Sofosbuvir in bulk form.