Development of an LC-Tandem Mass Spectrometry Method for the Separation of Montelukast and its Application to a Pharmacokinetic Study in Humans

Abstract

Accurate, precise, and sensitive LC-MS/MS assay method for the determination of montelukast (MO) in human plasma samples using gliclazide (GL) as internal standard was developed and applied in pharmacokinetics study.

MO extracted by protein precipitation using acetonitrile. Chromatographic separation was carried out using a Agilant Triple quadrupoles mass spectrometer with API source with an Agilant SB- C₁₈ (50×4.6 mm), 1.8 µm particle size column. A mobile phase consisting of acetonitrile: 0.1% formic acid (84:16) was delivered. Calibration curves were linear in the concentration range of (10.00–800.00) ng/ml. The bioanalytical method for determination of MO was successfully applied to assess pharmacokinetics of montelukast. The LLOQ was sensitive enough for detecting terminal phase concentrations of the drug. This study showed that developed method is suitable for MO pharmacokinetic study.

Key words

montelukast - gliclazide - LC-MS/MS - pharmacokinetic

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