Abstract

STRESS DEGRADATION STUDIES OF FUROSEMIDE AND DEVELOPMENT AND VALIDATION OF SIAM RP-HPLC METHOD FOR ITS QUANTIFICATION

Dr. Shailesh Sharma and Mitesh Phale*

ABSTRACT

Stress degradation studies have been carried out on Furosemide and novel SIAM RP-HPLC method has been developed and validated for quantitative analysis of Furosemide. Use of a Supelcosil C8 (250 mm × 4.6 mm, 5-μm particle size) column. The mobile phase was 70:30 (v/v) of 0.2 g of potassium dihydrogen orthophosphate and 0.25 g of cetrimide in 70 mL of water adjust the pH to 7.0 with 6M ammonia and add 30 mL of 1-propanol as isocratic mobile phase enabled separation of the drug from its degradation products. The flow rate and detection wavelength were 1 ml/min and 238 nm respectively. The method was validated for linearity, limits of detection and quantification, accuracy, precision and robustness. The linearity of the method was excellent over the range 16–24μg/ml. RSD in intra-day and inter-day precision studies was < 2%. Recovery of Furosemide from bulk drug ranged from 99.59 and 102.33%. Furosemide was subjected to stress conditions (hydrolysis (acid, base), oxidation, photolysis, and thermal degradation) and the stressed samples were analyzed by use of the method. The degradation products were the related impurities and were well resolved from main peak thus proving the stability indicating nature of the method.

Keywords: Furosemide; Stress degradation; SIAM; related impurities.