Abstract

DEVELOPEMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE ESTIMATION OF METOPROLOL AND IVABRADINE IN SOLID DOSAGE FORM

Bidkar J. S.*, Vare S.R., Dama G. Y., Shelke M. M. and Dhokare A. M.

Abstract

A simple, Accurate, precise method was developed for the simultaneous estimation of the Metoprolol and Ivabradine in Tablet dosage form. Chromatogram was run through Agilent C18 150 x 4.6 mm, 5. Mobile phase containing Buffer 0.01N KH2PO4 (3.75pH): Acetonitrile taken in the ratio 50:50 was pumped through column at a flow rate of 0.8 ml/min. Buffer used in this method was 0.01N KH2PO4. Temperature was maintained at 30°C. Optimized wavelength selected was 260.0nm. Retention time of Metoprolol and Ivabradine were found to be 2.461min and 3.309min. %RSD of the Metoprolol and Ivabradine were and found to be 0.7 and 0.7 respectively. % Recovery was obtained as 100.14% and 100.01% for Metoprolol and Ivabradine respectively. LOD, LOQ values obtained from regression equations of Metoprolol and Ivabradine were 0.41, 1.23 and 0.28, 0.85 respectively. Regression equation of Metoprolol is y = 12344x + 11645. And y = 23564x + 1992.2 of Ivabradine. Retention times were decreased and run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.

Keywords: Metoprolol, Ivabradine, RP-HPLC, Excipients, Validation.