High-performance liquid chromatographic assay for the simultaneous determination of lansoprazole enantiomers and metabolites in human liver microsomes

• Published in: Journal of chromatography. B, Biomedical sciences and applications Biomedical sciences and applications, 2001-06, Vol.757 (1), p.127-133
• Main Authors: Katsuki, Hisakazu, Hamada, Akinobu, Nakamura, Chizuko, Arimori, Kazuhiko, Nakano, Masahiro
• Format: Article
• Language: English
• Subjects: 2-Pyridinylmethylsulfinylbenzimidazoles; 5-Hydroxylansoprazole; Analysis; Biological and medical sciences; Calibration; Chromatography, High Pressure Liquid - methods; General pharmacology; Humans; Lansoprazole; Lansoprazole sulfone; Medical sciences; Microsomes, Liver - metabolism; Omeprazole - analogs & derivatives; Omeprazole - metabolism; Pharmacology. Drug treatments; Reproducibility of Results; Sensitivity and Specificity; Spectrophotometry, Ultraviolet; Stereoisomerism
• ISSN: 0378-4347; 1387-2273
• DOI: 10.1016/S0378-4347(01)00135-9

In this study, a simple, sensitive and enantioselective HPLC method was developed for the simultaneous determination of lansoprazole enantiomers: a proton pump inhibitor, and its major metabolites: 5-hydroxylansoprazole and lansoprazole sulfone in human liver microsomes. After extraction from the microsomal incubation mixture with a diethyl ether–dichloromethane (7:3, v/v) mixture, analytes were measured by reversed-phase HPLC on a Chiralcel ® OD-R column. Detection was made using an ultraviolet absorbance detector set at a wavelength of 285 nm. The mobile phase consisted of a methanol–water (75:25, v/v) mixture. At a flow-rate of 0.5 ml/min, the total run time was 35 min. The limit of quantification for both lansoprazole enantiomers was 0.25 μ M and for the metabolites 0.13 μ M. The method is suitable for the analysis of lansoprazole enantiomers and its metabolites from human microsomal liver incubations.