Chemical stability of enalapril maleate drug substance and tablets by a stability-indicating liquid chromatographic method

Química Nova

Diego, Marta de¹  Godoy, Ricardo¹  University of Concepción, Concepción, Chile¹  Godoy, Gloria¹  Mennickent, Sigrid¹ 

关键词: enalapril;    stability;    liquid chromatography.;   

DOI  :  10.1590/S0100-40422011000300016

学科分类：化学（综合）

来源: Sociedade Brasileira de Quimica

【 摘 要 】

The chemical stability of enalapril drug substance and tablets was studied by a stability-indicating liquid chromatographic method. Stress testing was performed on drug substance under various conditions. Accelerated stability testing was carried out for different formulations of enalapril tablets. Chromatographic separation was achieved on a RP-18 column, using a mobile phase of methanol phosphate buffer at 1.0 mL min"1 and UV detection. Degradation of the drug substance was greater under hydrolytic conditions. After 180 days of accelerated stability testing most enalapril tablets showed more than 10% of degradation. Enalapril drug substance and tablets showed instability under stress and accelerated testing respectively, with possible implications on the therapeutic activity.

【 授权许可】

Unknown