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Stability-indicating proton nuclear magnetic resonance spectroscopic assay method for furosemide in tablets and
1U.S. Food and Drug Administration, New York Regional Laboratory, Brooklyn 11232.
Abstract:
A simple, specific, and accurate proton nuclear magnetic resonance (1H-NMR) spectroscopic method has been developed for the identification and assay of furosemide and its degradation product, 4-chloro-5-sulfamoylanthranilic acid (CSA), in tablets and injections. Dissolution of the sample in D2O-NaOD resulted in a solution yielding the required separation among the resonance signals of furosemide, CSA, and tert-butyl alcohol, the internal standard. The mean +/- SD recovery values of furosemide and CSA from 10 synthetic formulations were 99.6 +/- 0.8 and 98.9 +/- 1.7%, respectively. Commercial tablets (6 lots) and injections (5 lots) of furosemide were assayed by the proposed method and found to contain 53.1-99.8% furosemide and 0.3-45.2% CSA.
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