Development and validation of stability-indicating methods for determination of torsemide

Abstract

Four sensitive and precise methods for determination of torsemide in presence of its degradation product and in pharmaceutical formulation were developed and validated. Method A is the second derivative spectrophotometry at 262.4 nm with mean percentage recoveries 100.06±0.75. Method B is first derivative of the ratio spectra spectrophotometry, at 232.4, 244.6 nm and at the total peak amplitude from the maximum at 232.4 nm to the minimum at 244.6 nm (¹DD_{232.4+244.6nm}). Method C is a TLC-densitometric one, for torsemide separation using acetone : chloroform : ethyl acetate (4:4:2 v/v) as a developing system. Method D is HPLC one, it provides complete separation of torsemide from its degradation product on C8 column with UV detection at 287 nm and recovery 99.98±0.76. The proposed methods have been successfully applied to the analysis of torsemide in pharmaceutical formulations without interference from other additives and the results were statistically compared with the official method.

KEY WORDS: HPLC, Stability-indicating, Spectrophotometry, TLC-densitometry, Torsemide

Bull. Chem. Soc. Ethiop. 2016, 30(1), 13-25.

DOI: http://dx.doi.org/10.4314/bcse.v30i1.2