A new validated stability indicating LC method for simultaneousdetermination of metoprolol succinate and ramipril in pharmaceuticalmarketed formulation

摘要

A simple and precise stability indicating RP-HPLC method was developed and validated for simultaneous determination of Metoprolol succinate and Ramipril in bulk and Pharmaceutical marketed formulation. Chromatography was carried out on Altima C18 (150 x 4.6 mm, 5m particle size) column in an isocratic mode with mobile phase containing phosphate buffer (adjusted to pH 4.8 with dilute othophosphoric acid, acetonitrile and methanol in the ratio of 35:10:55 v/v/v at a flow rate of 1ml/min. The analyte was monitored using PDA detector at 210 nm. The retention time was found to be 2.203 min and 3.283 min for Metoprolol succinate and Ramipril respectively. The proposed method was found to be having linearity in the concentration range of 5-30 μg/ml for Metoprolol succinate and 0.5-3.0 μg/ml for Ramipril with correlation coefficient value of 0.999 respectively. The mean recoveries obtained were found to be 99.87-100.24 for Metoprolol succinate and 99.64-100.08 for Ramipril respectively. Stress testing which covered acid, base, peroxide, UV light, neutral and thermal degradation was performed on under test to prove the specificity of the method and the degradation was achieved. The developed method has been statistically validated according to ICH guide lines. Thus the proposed method can be successfully applied for the stability indicating simultaneous determination of Metoprolol succinate and Ramipril in bulk and combined tablet dosage form and in routine quality control analysis.