Development and validation of a method for quantitative determination of valsartan in human plasma by liquid chromatography-tandem mass spectrometry

被引：64

作者：

Koseki, Nozomu ^{[1
]}

Kawashita, Hiroto ^{[1
]}

Hara, Hisanori ^{[1
]}

Niina, Miyuki ^{[1
]}

Tanaka, Makoto ^{[1
]}

Kawai, Ryosei ^{[1
]}

Nagae, Yusuke ^{[1
]}

Masuda, Naoki ^{[1
]}

机构：

[1] Novartis Pharma KK, Tsukuba Res Inst, Drug Metab & Pharmacokinet, Tsukuba, Ibaraki 3002611, Japan

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2007年 / 43卷 / 05期

关键词：

liquid chromatography-tandem mass spectrometry; valsartan; human pharmacokinetics; matrix effects; inter-subject variability;

D O I：

10.1016/j.jpba.2006.12.030

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

A sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the determination of valsartan in human plasma was developed and validated. A 0.5 ml aliquot was extracted using solid-phase extraction in an Empore(R) high performance extraction disk plate, universal resin 96-well formal. The estimated calibration range of the method was 2-2000 ng/ml. The method was fully validated with intra-day mean accuracy and precision of 94.8-107% and 2.19-5.40% and inter-day mean accuracy and precision of 93.5-105% and 1.87-5.67%, respectively. No significant loss of valsartan in processed samples was confirmed in processed samples for up to 24h at 10 degrees C. Sample dilution up to 50-fold with blank human plasma provided acceptable analyses. No interference peaks or matrix effects were observed. No effect of QC sample location results was observed in a 96-well plate. This LC-MS/MS technique was found to improve quantitative determination of valsartan allowing its pharmacokinetic evaluation with clinically relevant doses. (C) 2007 Elsevier B.V. All rights reserved.

引用

页码：1769 / 1774

页数：6

共 14 条

[11] Matrix effects: The Achilles heel of quantitative high-performance liquid chromatography-electrospray-tandem mass spectrometry [J].