Capillary electrophoresis with laser-induced fluorescence:: a routine method to determine moxifloxacin in human body fluids in very small sample volumes

被引:94
作者
Möller, JG
Stass, H
Heinig, R
Blaschke, G
机构
[1] Bayer AG, Clin Pharmacokinet, Inst Clin Pharmacol, D-42096 Wuppertal, Germany
[2] Univ Munster, Inst Pharmaceut Chem, D-48149 Munster, Germany
来源
JOURNAL OF CHROMATOGRAPHY B | 1998年 / 716卷 / 1-2期
关键词
moxifloxacin; microdialysate;
D O I
10.1016/S0378-4347(98)00302-8
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
The feasibility of capillary electrophoresis with HeCd laser-induced fluorescence detection as a validated routine method for bioanalytical analysis is reported. Method evaluation, validation and results of the determination of moxifloxacin (BAY 12-8039), a new antimicrobially active g-methoxy-quinolone, in plasma and microdialysate are described. After a one step sample preparation the samples can be injected directly into the capillary. The volume of microdialysate and plasma, respectively, needed for more than 50 injections is only 10 mu l and 20 mu l. Total run time is less than 7 min using a 27 cm capillary on commercial instrumentation. An analysis time of less than 1 min was shown to be possible, however it could not be used routinely since appropriate instrumentation was not available. Evaluation is based on the relative corrected peak area (analyte/I.S.). The method's dynamic range comprises three orders of magnitude (plasma: 2.5-5000 mu g/l; microdialysate: 5-5000 mu g/l). Validation according to international guidelines yielded data on accuracy and precision of the method throughout the entire working range of;inter-day precision: plasma <6%, microdialysate <5% and inter-day accuracy: plasma <2%, microdialysate <4%. The crossvalidation with an existing HPLC method utilizing clinical study samples shows Linear correlation. In view of its adequate sensitivity and high selectivity capillary electrophoresis with laser-induced fluorescence is a very versatile tool in pharmacokinetic studies of quinolones, especially in situations with limited sample volumes: e. g. pediatrics, patients at risk, animal-, microdialysis- and tissue-kinetic studies. Validation parameters and other features, like high sample throughput and robustness, are comparable to or even better than HPLC. Further necessary improvements of the capillary electrophoresis with laser-induced fluorescence instrumentation (autosampler, vials, parallel capillaries) and its use in bioanalytical routine analysis are discussed. (C) 1998 Elsevier Science B.V. All rights reserved.
引用
收藏
页码:325 / 334
页数:10
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