Simultaneous determination of ornidazole and its main metabolites in human plasma by LC-MS/MS: application to a pharmacokinetic study.
BACKGROUND
Ornidazole is a 5-nitroimidazole antimicrobial agent used for almost 40 years. A novel LC-MS/MS assay was developed and validated for the simultaneous determination of ornidazole and its main metabolites (M3, M6, M16-1, and M16-2) in human plasma.


RESULTS
After extraction from 100 μl of plasma by protein precipitation with acetonitrile, all the analytes were separated on a Capcell PAK MG C18 column (100 × 4.6 mm, 5 μm) within 5.0 min and detected by ESI-MS/MS in the positive mode. The validation results met the acceptance criteria as per the US FDA and EMA guidelines.


CONCLUSIONS
The validated method was successfully applied to a pharmacokinetic study after oral administration of 1000 mg ornidazole to six healthy Chinese volunteers.
State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, 501 Haike Road, Shanghai 201203, PR China.
Jiangbo
J
Du
Zhiyu
Z
Ma
Yifan
Y
Zhang
Ting
T
Wang
Xiaoyan
X
Chen
Dafang
D
Zhong
D000328:Adult; D001774:Blood Chemical Analysis / Q000379:methods*; D002853:Chromatography, Liquid / Q000379:methods*; D006801:Humans; D057230:Limit of Detection; D016014:Linear Models; D008297:Male; D009950:Ornidazole / Q000097:blood* / Q000378:metabolism / Q000493:pharmacokinetics*; D053719:Tandem Mass Spectrometry / Q000379:methods*; D013997:Time Factors; D055815:Young Adult
D009950:Ornidazole