Kinetics of degradation of enalapril maleate in dosage forms.
The effect of humidity and temperature on the stability of enalapril maleate (ENA) in tablets have been studied. Tablets with ENA were stored in final packs (blisters) and without final packs in the atmosphere of increased humidity (76.4 % RH) and in the temperature range from 313 K to 333 K (forced degradation test). Degradation of ENA in tablets stored in final packs and without final packs followed the first order reaction model. During this study, the product of hydrolysis of the ester group and intramolecular cyclization have been observed. Thermodynamic parameters (activation energies, enthalpy and entropy) for the decomposition of ENA in tablets were calculated.
Stanisz
Beata
B
Poznań University of Medical Sciences, Department of Pharmaceutical Chemistry, 60-780 Poznań, Poland. bstanisz@amp.edu.pl
D000806:Angiotensin-Converting Enzyme Inhibitors / Q000008:administration & dosage / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D004356:Drug Storage; D004656:Enalapril / Q000008:administration & dosage / Q000737:chemistry*; D006813:Humidity; D007202:Indicators and Reagents; D007700:Kinetics; D013607:Tablets; D013696:Temperature
D000806:Angiotensin-Converting Enzyme Inhibitors; D007202:Indicators and Reagents; D013607:Tablets; D004656:Enalapril