Stability-indicating Rp-HPLC method for the estimation of Metoprolol Succinate and Hydrochlorothiazide in tablet dosage form

Abstract

An easy, specific, accurate and precise RP-HPLC method was developed and validated for the concurrent estimation of metoprolol succinate and hydrochlorothiazide in pharmaceutical formulation with forced degradation studies. The method was developed by means of Enable C 18G column (250 ×4.6 mm, 5 µm) with mobile phase consisting of acetonitrile and 0.05 % trifluoroacetic acid in water (70:30 %v/v) with a flow rate of 0.7 mL/min. UV detection was carried out at 222 nm. The retention time for metoprolol succinate and hydrochlorothiazide were found to be 4.012 and 4.698 min respectively. The proposed method was validated for linearity, range, accuracy, precision, robustness, LOD and LOQ. Linearity was observed over a concentration range 2-40 µg/ml for metoprolol succinate (r2 =0.9999) and 0.5-80 µg/ml for hydrochlorothiazide (r2 =0.9990). The % RSD for intraday and nterday precision was found to be 0.57 and 0.68 for metoprolol succinate and 0.52 and 0.41 for hydrochlorothiazide. The LOD and LOQ were found to be 0.05 µg/ml and 0.16 µg/ml for metoprolol succinate and LOD and LOQ were found to be 0.04 and 0.15 µg/ml for hydrochlorothiazide respectively. Metoprolol succinate and hydrochlorothiazide were subjected to stress conditions of degradation including acidic, alkaline, oxidative, thermal and photolysis.