Stability Indicating Rp-hplc Method for Simultaneous Determination of Frusemide and Amiloride Hydrochloride in Tablet Dosage Form

This article focuses on stability indicating RP-HPLC method for simultaneous estimation of Frusemide and Amiloride Hydrochloride as API and in tablet dosage form, validation of developed method and its application in pharmaceutical companies. Acetonitrile, potassium di hydrogen phosphate and phosphoric acid were used. Chromatographic conditions comprised of C18 column (250 × 4.6 mm, 5 μm), mobile phase of phosphate buffer pH 3.0 and acetonitrile in 50:50 ratio, flow rate at 1 ml/min, ultraviolet detection at 283 nm. The retention time of Frusemide was found to be 3.038 min. and Amiloride Hydrochloride was 10.002 min. respectively. The linear regression analysis for calibration plots showed correlation coefficient, r = 0.99995 at concentration range of 20 to 200 μg/ml for Frusemide and r = 0.99925 at concentration range of 10 to 100 μg/ml for Amiloride hydrochloride. The stability studied indicated that the drugs are susceptible to wet heat, dry heat, day light, acidic and alkaline conditions with maximum degradation in oxidation degradation. Statistical analysis proved the developed RP-HPLC method as simple, reproducible and selective for the estimation of Frusemide and Amiloride hydrochloride in tablet dosage form and it can be employed as stability-indicating method.