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A stability indicating LC method for simultaneous determination of torsemide, spironolactone and their related substances in tablet formulation

Pradnya.A.Karbhari, Suvarna.I.Bhoir, Sneha.J.Joshi

An isocratic reverse phase liquid chromatography method has been developed for quantitative determination of Torsemide and Spironolactone alongwith their related compounds using a 150 X 4.6mm, 5µ Hypersil BDS C8 column with a mobile phase composition of buffer pH 5.0: methanol in equal quanitites. The flow rate was 1.0mL min -1 and wavelengthwas set at 260 nm. Resolution between torsemide and its impurity, and that due to Spironolactone and its impurity canrenone was more than 2.0 and 3.0 respectively. The method was validated for selectivity, linearity, accuracy, precision, limit of detection and limit of quantitation. Impurities of torsemide and spironolactone gave linear response. For the assay study torsemide and spironolactone showed linear response. The stress studies showed that the method was specific, selective to study torsemide, spironolactone and impurity1, impurity 2, impurity 3 of torsemide and impurity 4 of spironolactone. The peak purity of analyte showed that unknown degradation products formed during stress studies did not interfere with the determination of all the studied analytes. The