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Please use this identifier to cite or link to this item: http://hdl.handle.net/123456789/17205

Title: Effects of alkali and simulated gastric and intestinal fluids on danazol stability
Authors: E. A. Gadkariem
H. A. El-Obeid
M. A. Abounassif
S. M. Ahmed
Keywords: Danazol; HPLC; Degradation product; Base-catalysis
Issue Date: 2003
Publisher: Journal of Pharmaceutical and Biomedical Analysis
Abstract: The degradation kinetics of methanolic solution of danazol (0.020% w/v) in aqueous buffers and sodium hydroxide was investigated using stability-indicating HPLC method. The drug degrades in alkaline medium through a base-catalysed proton abstraction rather than via an oxidative mechanism involving oxygen species. The degradation followed pseudo-first-order kinetics. The rates pH-profile exhibited specific base catalysis. The stability of the drug was found to be dependent on pH, buffer concentration, buffer species (acetate, borate, phosphate) and temperature. The ionic strength did not affect the stability of the drug. The energy of activation according to Arrhenius plot was estimated to be 22.62 kcal mol−1 at pH 12 and temperatures between 30 and 60 °C. The effect of simulated gastric and intestinal fluids on the drug stability was also investigated. Two major hydrolytic degradation products were separated and identified by IR, NMR and mass spectrometry and the degradative pathway suggested..
URI: http://hdl.handle.net/123456789/17205
Appears in Collections:College of Pharmacy

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