Validated LC-MS/MS method for quantification of gabapentin in human plasma: application to pharmacokinetic and bioequivalence studies in Korean volunteers

被引:17
作者
Park, Jin-Hee
Jhee, Ok-Hwa
Park, Song-Hee
Lee, Jung-Sik
Lee, Min-Ho
Shaw, Leslie M.
Kim, Kwang-Hyun
Lee, Jong-Ho
Kim, Yong-Seok
Kang, Ju-Seop [1 ]
机构
[1] Hanyang Univ, Dept Pharmacol, Coll Med, Dept Bioengn, Seoul 133791, South Korea
[2] Hanyang Univ, Inst Biomed Sci, Coll Med, Dept Bioengn, Seoul 133791, South Korea
[3] Gongju Natl Univ Educ, Dept Pract Arts Educ, Chungnam 314711, South Korea
[4] Hanyang Univ, Dept Internal Med, Coll Med, Seoul 133791, South Korea
[5] Univ Penn, Dept Pathol & Lab Med, Coll Med, Philadelphia, PA 19104 USA
[6] Bio Mediang Co, Pharmacokinet Lab, Gyunggi Do 463070, South Korea
[7] Hutecs Korea Pharm Co Ltd, R&D Ctr, Gyunggi Do 445813, South Korea
[8] Hanyang Univ, Dept Biochem, Seoul 133791, South Korea
关键词
LC-MS/MS; gabapentin; pharmacokinetics; bioequivalence study;
D O I
10.1002/bmc.826
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
A sensitive validated liquid chromatography-tandem mass spectrometric method (LC-MS/MS) for gabapentin (GB) in human plasma has been developed and applied to pharmacokinetic (PK) and bioequivalence (BE) studies in human. In a randomized crossover design with a 1 -week period, each subject received a 300 mg GB capsule. The procedure involves a simple protein precipitation with acetonitrile and separated by LC with a Gemini C-18 column using acetonitrile-10 mM ammonium acetate (20:80, v/v, pH 3.2) as mobile phase. The GB and internal standard [(S)-(+)-alpha-aminocyclohexanepropionic acid hydrate] were analyzed using an LC-API 2000 MS/MS in multiple reaction monitoring mode. The ionization was optimized using ESI(+) and selectivity was achieved using MS/MS analysis, m/z 172.0 -> 154.0 and m/z 172.0 -> 126.0 for GB and IS, respectively. The assay exhibited good linearity over a working range of 20-5000 ng/mL for GB in human plasma with a lower limit of quantitation of 20 ng/mL. No endogenous compounds were found to interfere with the analysis. The accuracy and precision were shown for concentrations over the standard ranges. This method was successfully applied for the PK and BE studies by analysis of blood samples taken up to 36 h after an oral dose of 300 mg of GB in 24 healthy volunteers. Copyright (C) 2007 John Wiley & Sons, Ltd.
引用
收藏
页码:829 / 835
页数:7
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