http://jcps.bjmu.edu.cn

• 研究论文 • 上一篇    下一篇

LC-ESI-MS 方法测定人血浆中孟鲁司特含量及其药代动力学的研究

黄瑶1, 丁黎1*, 刘园园1, 刘荷英1, 文爱东2, 杨林2   

  1. 1. 中国药科大学 药物分析教研室, 江苏 南京 210009
    2. 第四军医大学西京医院 国家药品临床研究基地, 陕西 西安 710032
  • 收稿日期:2009-05-12 修回日期:2009-08-10 出版日期:2009-09-15 发布日期:2009-09-15
  • 通讯作者: 丁黎*

Determination of montelukast in human plasma by LC-ESI-MS and its application in pharmacokinetic study

Yao Huang1, Li Ding1*, Yuan-Yuan Liu1, He-Ying Liu1, Ai-Dong Wen2, Lin Yang2   

  1. 1. Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing 210009, China
    2. Xijing Hospital affiliated to the Fourth Military Medical University, Xi'an 710032, China
  • Received:2009-05-12 Revised:2009-08-10 Online:2009-09-15 Published:2009-09-15
  • Contact: Li Ding*

摘要: 建立人血浆中孟鲁司特的LC-ESI-MS测定方法。孟鲁司特钠血浆样品用乙腈沉淀蛋白后, 经C18柱分离, 流动相为20 mmol/L醋酸铵缓冲盐溶液(包含0.2%甲酸)-甲醇(12:88, v/v)。LC-ESI-MS测定法采用选择性离子监测模式(SIM), 检测离子为孟鲁司特的[M+H]+ m/z 586.2和内标替米沙坦的[M+H]+离子 m/z 515.2, 线性范围是1 ng/mL-1000 ng/mL, 最低定量限为1 ng/mL, 方法的批内和批间相对标准偏差(精密度)分别小于5.9%和10.0%。此方法已成功地用于孟鲁司特钠片剂在中国健康受试者体内的药动学研究。

关键词: 孟鲁司特, LC-ESI-MS, MS, 药动学

Abstract:

A liquid chromatography-electrospray ionization-mass spectrometry (LC-ESI-MS) method was developed for the determination of montelukast in human plasma. After precipitation of plasma proteins, the plasma samples were separated on a C18 column with a mobile phase consisted of 20 mmol/L ammonium acetate buffer solution containing 0.2% formic acid-methanol (12:88, v/v). LC-ESI-MS was performed in the selected-ion monitoring (SIM) mode using target ions [M+H]+ at m/z 586.2 for montelukast and m/z 515.2 for telmisartan, the internal standard (IS). The calibration curve was linear over the plasma concentration range of 1 ng/mL-1000 ng/mL. The lower limit of quantification (LLOQ) was 1 ng/mL for montelukast. The relative standard deviations of intra- and inter-batches were less than 5.9% and 10.0%, respectively. The method was successfully applied to study the pharmacokinetics of montelukast sodium tablets in healthy Chinese volunteers.

Key words: Montelukast, Montelukast, LC-ESI-MS, LC-ESI-MS, MS, MS, Pharmacokinetics, Pharmacokinetics

中图分类号: 

Supporting:

*Corresponding author. Tel.:/ fax: 86-25-83271289; e-mail: dinglidl@hotmail.com