HPLC study of glimepiride under hydrolytic stress conditions.
Glimepiride is a modern hypoglycaemic agent, which belongs to the group of sulfonylurea derivates. In this paper, simple, specific and accurate RP-HPLC method was developed in order to study decomposition of glimepiride under the hydrolytic stress conditions (acid, neutral, alkaline and oxidative). The best separation of glimepiride and its degradation products was achieved on reverse phase C18 column. The mobile phase was composed of acetonitrile-phosphate buffer (pH 3.5, 0.03 M) (48:52, v/v). Employing RP-HPLC method, five main degradation products were detected in the exposed samples. It was found that the susceptibility of glimepiride to hydrolytic decomposition increased in following manner: neutral condition < alkaline condition < acid condition < oxidative condition.
Kovaríková
Petra
P
Department of Pharmaceutical Chemistry and Drug Control, Faculty of Pharmacy in Hradec Kralove, Charles University in Prague, Heyrovskeho 1203, 50005 Hradec Kralove, Czech Republic. kovarikova@faf.cuni.cz
Klimes
Jirí
J
Dohnal
Jirí
J
Tisovská
Lucie
L
D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004355:Drug Stability; D006868:Hydrolysis; D010084:Oxidation-Reduction; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013453:Sulfonylurea Compounds / Q000032:analysis* / Q000737:chemistry
D013453:Sulfonylurea Compounds; C057619:glimepiride