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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*

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

CLC Number: 

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