A stability indicating assay method development and validation for simultaneous estimation of OlmesartanMedoxamil and Metoprolol Succinate in bulk and pharmaceutical dosage form by RP-HPLC method

A simple, sensitive and reproducible stability indicating RP-HPLC method for the simultaneous determination of Olmesartan medoxomil (OLM) and Metoprolol succinate (METP) in bulk and Pharmaceutical dosage form has been developed and validated. Chromatographic separation was carried out on Thermo Hypersil BDS C18 (4.6 x 250 mm, 5µ particle size) column using a mobile phase composed of acetonitrile: phosphate buffer (adjusted to pH 4.8 with 0.1 % OPA) in the ratio of 50:50 % v/v at a flow rate of 1.0 ml/min. The analyte was monitored using UV detector wavelength at 219 nm. The retention time was found to be 2.753 min and 4.112 min for Olmesartan medoxomil and Metoprolol succinate respectively. The proposed method was found to be having linearity in the concentration range of 5-30 µg/ml for Olmesartan medoxomil (r2 0.99991) and 6.5-37.5 µg/ml for Metoprolol succinate (r2 0.99994) respectively. The mean % recoveries obtained were found to be 99.86–100.01% for Olmesartan medoxomil and 99.94–100.17% for Metoprolol succinate respectively. Stress testing which covered acid, alkali, peroxide, photolytic 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. The proposed method can be successfully applied for the stability indicating RP-HPLC simultaneous determination of Olmesartan medoxomil (OLM) and Metoprolol succinate (METP) in bulk and combined tablet dosage form and in routine quality control analysis.

Author(s): Mohammad Yunoos and D. Gowri Sankar1 and P. Satyanarayana Reddy

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