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Original Article

J App Pharm Sci. 2019; 9(4): 137-144


Stability Indicating RP-HPLC Method for the Simultaneous Estimation of Ivabradine and Metoprolol in Bulk and Tablet Formulation

Sangameshwar B. Kanthale, Sanjay S. Thonte, Debarshi Kar Mahapatra.


Abstract

A new, accurate, precise, and robust RP-HPLC method has been developed along with sensitive stability indicating attributes for the simultaneous estimation of ivabradine (IVA) and metoprolol (MET) in both bulk and tablet formulation. The estimation of the solutes was performed on a Denali C18 column of dimension 150 mm × 4.6 mm, 5μm. IVA and MET were eluted with OPA (0.1%) buffer: acetonitrile in the ratio of 60:40 v/v in a 6 min isocratic trial at a flow rate of 0.8 ml/min having an ambient column temperature 30°C and monitored at 260 nm wavelength. The retention time of IVA and MET was found to be 2.290 min and 3.520 min, respectively. The Q2b validation of the analytical method revealed good linearity over the concentration range 5-30 μg/mL for IVA and 25-150 μg/mL for MET with r2 of 0.999 in both the cases. The mean recovery % over the three tested ranges of 50%, 100%, and 150% were found to be 100.46%, 99.68%, and 99.68%, respectively. The accuracy and precision data expressed < 2% RSD value along with adequate robustness after deliberate alteration in the mobile phase composition, flow rate, and column temperature. The acid, alkali, dry heat, peroxide-induced stress studies presented the formation of a variety of degradation products. The developed analytical method was precise, accurate, and robust for the routine analysis of the drug combination in bulk and tablet formulations.

Key words: Ivabradine, Metoprolol, Simultaneous, Validation, Degradation, Stability studies






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