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

Abstract

A new Reverse Phase High Performance Liquid chromatographic method was developed for the quantification of
Ledipasvir and Sofosbuvir. The chromatographic separation was achieved on a SHIMADZU Prominence HPLC ,
Zodiac - C18 (250 x 4.6 mm, 5 µ) column within a runtime of 10 min under isocratic elution Acetonitrile and
methanol and water at a flow rate of 1.0ml/min. UV detector set at 275nm was used for detection. The method was
validated according to the ICH guidelines with respect to specificity, precision, accuracy and linearity. The
proposed method was found to be reproducible and convenient for quantitative analysis of Ledipasvir and
Sofosbuvir, in bulk form.