Development and Validation of Stability-Indicating RP-HPLC Method for Determination of Metoprolol Suecinate and Olmesartan Medoxomil in Bulk and in Formulation

摘要

An accurate, precise, robust and economic stability-indicating RP HPLC method for determination of Metoprolol suecinate and Olmesartan medoxomil in bulk and in formulation has been developed and validated. Separation was carried out on HiQSil C18 column (250 x 4.6 mm, 5 mum) at flow rate of 1 ml/min using Methanol: 10 mM o-phosphoric acid buffer (50: 50 v/v) and detection at 216 nm. On a stabilized chromatographic condition Metoprolol suecinate and Olmesartan medoxomil gave acceptable peak at RT 3.66 ± 0.04 min and 18.14 ± 0.05 min, respectively. The calibration curve for Metoprolol suecinate and Olmesartan medoxomil was found to be linear in the range 1-25 mug/ml and 1-10 mug/ml, respectively. The method was validated in accordance with international conference on harmonization (ICH) guidelines and prescribed stress conditions. The drugs were subjected to stress condition of hydrolysis (acid, base, neutral), oxidation, photolysis and thermal degradation. The proposed method can be applicable for the routine determination of Metoprolol suecinate and Olmesartan medoxomil in bulk and formulation.