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1 2011

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Stability-indicating HPTLC method for analysis of torsemide in pharmaceutical preparations

Kakde R, Chaudhary N, Barsagade A, Kale D

Acta Chromatographica

2011

Vol. 23, no. 1

145--155

A simple, precise, and accurate stability-indicating high-performance thinlayer chromatographic method for analysis of torsemide in the presence of its degradation products has been established and validated. Optimum separation among torsemide and its degradation products was achieved by use of silica gel 60F254 as stationary phase with ethyl acetate-acetonitrile-water 6.5:3.0:0.5 (v/v) as mobile phase. Densitometric quantification was performed at 297 nm. The retention factors, RF, were 0.59 ± 0.02 for the parent drug, 0.74 ± 0.02 for the degradation product from oxidation, and 0.78 ± 0.02 and 0.96 ± 0.02 for two products of acid degradation. The method was found to be linear in the range 200–800 ng per band both by area and height. The results from analysis of commercial formulations were found to be 98.49 ± 0.32 and 101.75 ± 1.54%. The method was validated for precision, accuracy, specificity, robustness, and ruggedness.