Simultaneous determination of ornidazole and its main metabolites in human plasma by LC-MS/MS: application to a pharmacokinetic study
Simultaneous determination of ornidazole and its main metabolites in human plasma by LC-MS/MS: application to a pharmacokinetic study
复制标题
LC-MS/MS 同时测定人血浆中奥硝唑及其主要代谢物：在药代动力学研究中的应用。
DOI：
10.4155/bio.14.117
复制
发表时间：
2014-01-01
期刊：
影响因子：
1.8
通讯作者：
Zhong, Dafang
中科院分区：
文献类型：
--
作者：
Du, Jiangbo;Ma, Zhiyu;Zhong, Dafang
背景
奥硝唑是一种 5-硝基咪唑抗菌剂，已使用近 40 年。开发并验证了一种新型 LC-MS/MS 测定法，用于同时测定人血浆中的奥硝唑及其主要代谢物（M3、M6、M16-1 和 M16-2）。
结果
通过乙腈沉淀蛋白质从 100 μl 血浆中提取后，所有分析物在 Capcell PAK MG C18 柱（100 × 4.6 mm，5 μm）上在 5.0 分钟内分离，并在正模式下通过 ESI-MS/MS 进行检测。验证结果符合美国 FDA 和 EMA 指南的验收标准。
结论
该验证方法成功应用于六名健康中国志愿者口服1000 mg奥硝唑后的药代动力学研究。
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.
CONCLUSION
The validated method was successfully applied to a pharmacokinetic study after oral administration of 1000 mg ornidazole to six healthy Chinese volunteers.