LC-MS/MS method development and validation of Montelukast in human plasma and its clinical application

In the present paper, the authors described a novel Liquid chromatography–tandem mass spectrometry (LC–MS/MS) method for the determination of montelukast in human plasma using montelukast d6 as internal standard (IS). After solid phase extraction (SPE), the analyte and the IS were chromatographed on a C18 columns using a isocratic mobile phase composed of acetonitrile–5mM ammonium acetate (80:20, v/v) pumped at a flow rate of 0.8mL/min. The proposed method was validated in the range of 5.01–599.91 ng/mL as per the US FDA guidelines. Precision and accuracy results were calculated using five successful calibration curves. Analyte stability in true samples and in plasma samples under different conditions were established and results met the acceptance criteria. The chromatographic run time was set at 3 min, which makes the proposed method is high through put. The method was successfully applied to a pharmacokinetic study in healthy South Indian male subjects under fasting condition.