A NEW VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF GRAZOPREVIR AND ELBASVIR IN TABLET DOSAGE FORMSAbstract
A combination of Grazoprevir and Elbasvir is used to treat Hepatitis C virus (HCV). A selective, accurate and precise RP-HPLC method was developed and validated for the simultaneous estimation of these drugs in combined tablet dosage forms. The drugs were resolved on a BDS C18 column using 0.1% orthophosphoric acid: Acetonitrile (45:55 v/v) as the mobile phase. The detection wavelength was 260 nm. The retention times obtained for Grazoprevir and Elbasvir were 2.400 & 3.018 min respectively. The linearity ranges were 25-150 & 12.5-75µg/ml respectively with Regression coefficients of 0.999. The % R.S.D. of precision studies was found to be 0.6 & 0.4 respectively. The accuracy of the proposed method was determined by recovery studies and the mean recovery was 99.14 & 100.34%, respectively. The method was also applicable for quantitative analyses of the marketed tablet formulations and in studying the stability of the drugs under acidic, alkaline, oxidation, thermal and UV conditions.
D. V. Kumar * and J. V. L. N. S. Rao
School of Pharmaceutical Sciences & Technologies, Jawaharlal Nehru Technological University, Kakinada, Andhra Pradesh, India.
28 May 2019
04 October 2019
30 November 2019
01 April 2020