DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF IVABRADINE AND METOPROLOL IN TABLET DOSAGE FORMAbstract
The objective of the method is to develop a rapid, simple, accurate, precise RP-HPLC method for the simultaneous estimation of Ivabradine and Metoprolol in tablet dosage form. The analytes were run through BDS C18 150 × 46 mm, 5µm column, and detected at a wavelength of 260 nm using PDA 996 (photodiode array) detector. Mobile phase containing buffer 0.01N disodium hydrogen phosphate (3.5±1 pH) and acetonitrile in the ratio of 65:35 v/v was pumped through the column at a flow rate of 1.0ml/min and run time is about 6 min. The temperature was maintained at 30 °C. Retention times of ivabradine and metoprolol were found to be 2.38 min and 3.53 min. Percentage RSD of ivabradine and metoprolol was found to be 0.4 and 0.7, respectively. Percentage recovery of ivabradine and metoprolol were found to be 99.80% and 100.11%. LOD and LOQ values obtained from regression equations of ivabradine and metoprolol were found to be 0.03, 0.08, and 0.26, 0.79, respectively. The degradation studies were performed by applying different stress conditions like acidic, basic, thermal, photolytic, and results revealed that the method was a stable method. The developed method has good sensitivity, reproducibility, and specificity for the determination of ivabradine and metoprolol in bulk and its dosage form. The degradation studies were found to be stable and have the ability to separate degradation products in pharmaceutical dosage form and can be successfully applied for the simultaneous estimation of ivabradine and metoprolol in commercially available tablet dosage forms.
S. Rajakumari, G. Rajitha * and A. G. Susmita
Institute of Pharmaceutical Technology, Sri Padmavati Mahila Visvavidyalayam (Women’s University), Tirupati, Andhra Pradesh, India.
10 July 2019
20 February 2020
14 April 2020
01 June 2020