Torsemide is a loop diuretic and Spironolactone is a high ceiling diuretic, which belong to diuretics class of drugs. A simple,RP-HPLC method was developed for the simultaneous estimation of Torsemide and Spironolactone in bulk and tablet dosage form according to ICH guidelines. The mobile phase was 80% ACN with 0.1%OPA buffer at a flow rate of 1ml/min, wave length was 235 nm and elution was isocratic mode. Injection volume was 20 L RT was 3.1 &3.9, linearity concentrations were found to be 50-250 g/ml and 125-625 g/ml respectively. Correlation coefficient was r2=0.999. Recoveries were 99.7% & 99.4%. LOD/LOQ was also done for both the drugs which were subjected to acid, alkali treatments, photo degradation etc., the method validation was performed with respect to robustness, specificity, linearity, precision and accuracy as per ICH guidelines Q2(R1)
KEYWORDS: Torsemide, Spironolactone, RP-HPLC , Degradation studies, Validation process