Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ELBASVIR AND GRAZOPREVIR IN BULK AND TABLET DOSAGE FORMS

M. Lakshmi Surekha*, Muggu Muralikrishna and R. Padma

Abstract

A simple, rapid, accurate, precise and reproducible RP-HPLC method was developed for the estimation of Elbasvir and Grazoprevir in liquid dosage forms. The method was carried out using Inertsil ODS 3V(150mm x 4.6 mm), 5μm column in an binary mode with mobile phase comprising gradient mixture of pH 3.0 Potassium Di-Hydrogen phosphate and Acetonitrile. The flow rate was 1.2 ml/min and detection was carried out at 260 nm using a UV detector. The retention time for Elbasvir and Grazoprevir was found to be at 3.76 min and 9.74 min. The method for Elbasvir showed linearity in the concentration range of 153.7- 461μg/ml (R2=1.000) and for Grazoprevir showed linearity in the concentration range of 12.6- 37.8μg/ml (R2=1.000). The recovery studies for Elbasvir and Grazoprevir also carried out and %RSD for reproducibility was found to be below 2%. The method was simple, sensitive and specific. Hence method can be used for the quantification of Elbasvir and Grazoprevir in pharmaceutical dosage form.

Keywords: Elbasvir and Grazoprevir, RP-HPLC, validation.