Abstract
ABSTRACT − A rapid and specific high performance liquid chromatography-tandem mass (LC/MS/MS) method for theanalysis of montelukast in human plasma has been developed and validated. After cold acetonitrile-induced precipitation ofthe plasma samples, montelukast and glipizide (internal standard, IS) were eluted on a reverse-phase C 18 column by isocraticmobile 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) showedcorrelation coefficients (r 2 ) were better than 0.9948. Precision of intra- and inter-day ranged from 3.70 to 11.68% and from3.04 to 12.95%, accuracy of intra-day and inter-day ranged from 93.34 to 102.75% and from 100.79 to 107.63%, respec-tively. The described method provides a fast and sensitive analytical tool for determining montelukast levels in plasma, andwas successfully applied to a pharmacokinetic study in 16 healthy human subjects after oral administration of 10mg tabletformulation of montelukast sodium under fasting conditions.Key words
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