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Sensitive LC‐MS/MS‐ESI method for simultaneous determination of montelukast and fexofenadine in human plasma: application to a bioequivalence study
Author(s) -
Muppavarapu Rajendraprasad,
Guttikar Swati,
Rajappan Manavalan,
Kamarajan Kannan,
Mullangi Ramesh
Publication year - 2014
Publication title -
biomedical chromatography
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.4
H-Index - 65
eISSN - 1099-0801
pISSN - 0269-3879
DOI - 10.1002/bmc.3114
Subject(s) - fexofenadine , chemistry , chromatography , montelukast , ammonium formate , bioequivalence , electrospray ionization , selected reaction monitoring , analyte , pharmacokinetics , analytical chemistry (journal) , acetonitrile , tandem mass spectrometry , mass spectrometry , pharmacology , medicine , asthma
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‐ d 6 (MT‐ d 6 ) and fexofenadine‐ d 10 (FF‐ d 10 ), respectively as an internal standard (IS) as per the US Food and Drug Administration guidelines. The chromatographic resolution was achieved on a Chromolith RP 18e column using an isocratic mobile phase consisting of 20 m m 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‐ d 6 and FF‐ d 10 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.