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人血浆中阿那曲唑的亲水相互作用色谱-电喷雾电离串联质谱分析及其在药代动力学研究中的应用。

Hydrophilic interaction chromatography-electrospray ionization tandem mass spectrometric analysis of anastrozole in human plasma and its application to a pharmacokinetic study.

作者信息

Ji Hye Young, Sohn Ji-Hong, Lee Hye Suk

机构信息

Drug Metabolism and Bioanalysis Laboratory, College of Pharmacy, The Catholic University of Korea, Bucheon 420-743, Korea.

出版信息

Biomed Chromatogr. 2012 Feb;26(2):261-6. doi: 10.1002/bmc.1658. Epub 2011 Jun 8.

DOI:10.1002/bmc.1658
PMID:21656533
Abstract

A hydrophilic interaction chromatography-electrospray ionization tandem mass spectrometric method was developed for determination of anastrozole in human plasma. Anastrozole and irbesartan (internal standard) were extracted from human plasma with a mixture of dichloromethane and methyl tert-butyl ether (30:70, v/v). Analysis of the analytes was performed on a Luna HILIC column with the mobile phase of acetonitrile-10 m m ammonium formate (95:5, v/v) and detected by electrospray ionization tandem mass spectrometry in the selected reaction monitoring mode. The standard curve was linear (r(2)  = 0.9992) over the concentration range of 0.10-50.0 ng/mL using 200 μL of plasma sample. The coefficient of variation and relative error for intra- and inter-assay at four QC levels were 1.2-10.0% and -7.2-3.2%, respectively. The present method was applied successfully to the pharmacokinetic study of anastrozole after oral administration of 1 mg anastrozole tablet to healthy male volunteers.

摘要

建立了一种亲水相互作用色谱-电喷雾电离串联质谱法用于测定人血浆中阿那曲唑的含量。阿那曲唑和厄贝沙坦(内标)用二氯甲烷和甲基叔丁基醚(30:70,v/v)的混合物从人血浆中萃取。分析物在Luna HILIC柱上进行分析,流动相为乙腈-10 mM甲酸铵(95:5,v/v),并通过电喷雾电离串联质谱在选择反应监测模式下进行检测。使用200 μL血浆样品,在0.10 - 50.0 ng/mL的浓度范围内,标准曲线呈线性(r(2) = 0.9992)。四个质量控制水平下批内和批间的变异系数和相对误差分别为1.2 - 10.0%和 - 7.2 - 3.2%。该方法成功应用于健康男性志愿者口服1 mg阿那曲唑片后的药代动力学研究。

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