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

Quimica nova

Diego, Marta de¹  Godoy, Ricardo¹  Godoy, Gloria¹  Mennickent, Sigrid¹ 

[1] University of Concepción, Concepción, Chile

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 】

Thechemical stability of enalapril drug substance and tablets was studied by a stability-indicatingliquid chromatographic method. Stress testing was performed on drug substanceunder various conditions. Accelerated stability testing was carried out for differentformulations of enalapril tablets. Chromatographic separation was achieved ona RP-18 column, using a mobile phase of methanol phosphate buffer at 1.0 mL min"1and UV detection. Degradation of the drug substance was greater under hydrolyticconditions. After 180 days of accelerated stability testing most enalapril tabletsshowed more than 10% of degradation. Enalapril drug substance and tablets showedinstability under stress and accelerated testing respectively, with possible implicationson the therapeutic activity.

【 授权许可】

CC BY