Development and Validation of Stability Indicating RP-HPLC Method for Simultaneous Estimation of Ivabradine and Metoprolol in Tablet Dosage Form

    Published on:July 2019
    Journal of Young Pharmacists , 2019; 11(3):xx-xx
    Original Article | doi:10.5530/jyp.2019.11.x
    Authors:

    Sanapathi Rajakumari*, Galla Rajitha, Adepu Geetha Susmita

    Institute of Pharmaceutical Technology, Sri Padmavati Mahila Visvavidyalayam (Women’s University), Tirupati, Andhra Pradesh, INDIA.

    Abstract:

    Objectives: To develop a rapid, simple, accurate, precise method for simultaneous estimation of Ivabradine and Metoprolol in tablet dosage forms using RP-HPLC. Methods: The analytes were run through BDS C18 150 × 46 mm, 5μm column and detected at a wavelength of 260nm using PDA 996 (photo diode 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. Results: Retention times of ivabradine and metoprolol were found to be 2.38 min and 3.53 min. Percentage RSD of ivabradine and metoprolol were found to be 0.4 and 0.7 respectively. % 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. Conclusion: The developed method has good sensitivity, reproducibility and specificity for the determination of ivabradine and metoprolol in bulk and its dosage forms. The degradation studies were found to be stable and has ability to separate degradation products in pharmaceutical dosage forms and can be successfully applied for the simultaneous estimation of ivabradine and metoprolol in commercially available tablet dosage forms.

    Key words: Ivabradinne, Metoprolol, Simultaneous estimation, RP-HPLC.

     

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