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KMID : 0369820110410050289
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Jorunal of Korean Pharmaceutical Sciences
2011 Volume.41 No. 5 p.289 ~ p.294
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Pharmacokinetic Analysis of Montelukast in Healthy Korean Volunteers by High Performance Liquid Chromatography-Tandem Mass Spectrometry
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Jo Min-Ho
Park Mi-Sun
Seo Ji-Hyung
Shim Wang-Seob
Yim Sung-Vin
Lee Kyung-Tae
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Abstract
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A rapid and specific high performance liquid chromatography-tandem mass (LC/MS/MS) method for the analysis of montelukast in human plasma has been developed and validated. After cold acetonitrile-induced precipitation of the plasma samples, montelukast and glipizide (internal standard, IS) were eluted on a reverse-phase C18 column by isocratic mobile phase consisted of 10 mM ammonium formate buffer (adjusted to pH 3.5 with formic acid) and acetonitrile (3:97, v/v). Acquisition was performed with multiple reaction monitoring (MRM) mode by monitoring the transitions: m/z 587.2→423.2 for montelukast and m/z 446.0→321.2 for IS. Ranges of concentration for calibration curves (10-1000 ng/mL) showed correlation coefficients (r2) were better than 0.9948. Precision of intra- and inter-day ranged from 3.70 to 11.68% and from 3.04 to 12.95%, accuracy of intra-day and inter-day ranged from 93.34 to 102.75% and from 100.79 to 107.63%, respectively. The described method provides a fast and sensitive analytical tool for determining montelukast levels in plasma, and was successfully applied to a pharmacokinetic study in 16 healthy human subjects after oral administration of 10mg tablet formulation of montelukast sodium under fasting conditions.
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KEYWORD
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Montelukast, Pharmacokinetic study, Human plasma, LC/MS/MS, Korean
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