Sensitive LC‐MS/MS‐ESI method for simultaneous determination of montelukast and fexofenadine in human plasma: application to a bioequivalence study
- 15 January 2014
- journal article
- research article
- Published by Wiley in Biomedical Chromatography
- Vol. 28 (8), 1048-1056
- https://doi.org/10.1002/bmc.3114
Abstract
A rapid, simple, sensitive and selective LC‐MS/MS method was developed and validated for simultaneous quantification of montelukast (MT) and fexofenadine (FF) in human plasma (200 μL) using montelukast‐d6 (MT‐d6) and fexofenadine‐d10 (FF‐d10), respectively as an internal standard (IS) as per the US Food and Drug Administration guidelines. The chromatographic resolution was achieved on a Chromolith RP18e column using an isocratic mobile phase consisting of 20 mm ammonium formate–acetonitrile (20:80, v/v) at flow rate of 1.2 mL/min. The LC‐MS/MS was operated under the multiple‐reaction monitoring mode using electrospray ionization. The total run time of analysis was 4 min and elution of MT, FF, MT‐d6 and FF‐d10 occurred at 2.5, 1.2, 2.4 and 1.2 min, respectively. The standard curve found to be linear in the range 2.00–1000 ng/mL with a coefficient of correlation of ≥0.99 for both the drugs. The intra‐ and inter‐day accuracy and precision values for MT and FF met the acceptance as per FDA guidelines. MT and FF were found to be stable in a battery of stability studies viz., bench‐top, auto‐sampler and repeated freeze‐thaw cycles. The validated assay was applied to an oral bioequivalence study in humans. Copyright © 2014 John Wiley & Sons, Ltd.Keywords
This publication has 18 references indexed in Scilit:
- Quantification of the transporter substrate fexofenadine in cell lysates by liquid chromatography/tandem mass spectrometryRapid Communications in Mass Spectrometry, 2011
- Efficacy of leukotriene antagonists as concomitant therapy in allergic rhinitisThe Laryngoscope, 2010
- Validation and application of a liquid chromatography–tandem mass spectrometric method for quantification of the drug transport probe fexofenadine in human plasma using 96-well filter platesJournal of Chromatography B, 2010
- Method Development and Validation of Montelukast in Human Plasma by HPLC Coupled with ESI-MS/MS: Application to a Bioequivalence StudyScientia Pharmaceutica, 2010
- Measurement of fexofenadine concentration in micro‐sample human plasma by a rapid and sensitive LC‐MS/MS employing protein precipitation: application to a clinical pharmacokinetic studyBiomedical Chromatography, 2009
- Quantification of montelukast, a selective cysteinyl leukotriene receptor (CysLT1) antagonist in human plasma by liquid chromatography–mass spectrometry: validation and its application to a human pharmacokinetic studyBiomedical Chromatography, 2009
- LC–MS–MS Assay for Simultaneous Quantification of Fexofenadine and Pseudoephedrine in Human PlasmaChromatographia, 2008
- Rapid and Sensitive LC-MS/MS Method for Quantification of Fexofenadine in Human Plasma —– Application to a Bioequivalence Study in Chinese VolunteersChemical Research in Chinese Universities, 2007
- Simultaneous quantification of fexofenadine and pseudoephedrine in human plasma by liquid chromatography/tandem mass spectrometry with electrospray ionization: method development, validation and application to a clinical studyRapid Communications in Mass Spectrometry, 2006
- Determination of fexofenadine in human plasma using 96-well solid phase extraction and HPLC with tandem mass spectrometric detectionJournal of Pharmaceutical and Biomedical Analysis, 2004