Sensitive LC-MS/MS-ESI method for simultaneous determination of montelukast and fexofenadine in human plasma: application to a bioequivalence study

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 pe...

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Veröffentlicht in:Biomedical chromatography 2014-08, Vol.28 (8), p.1048-1056
Hauptverfasser: Muppavarapu, Rajendraprasad, Guttikar, Swati, Rajappan, Manavalan, Kamarajan, Kannan, Mullangi, Ramesh
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container_end_page 1056
container_issue 8
container_start_page 1048
container_title Biomedical chromatography
container_volume 28
creator Muppavarapu, Rajendraprasad
Guttikar, Swati
Rajappan, Manavalan
Kamarajan, Kannan
Mullangi, Ramesh
description 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.
doi_str_mv 10.1002/bmc.3114
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Chromatogr</addtitle><date>2014-08</date><risdate>2014</risdate><volume>28</volume><issue>8</issue><spage>1048</spage><epage>1056</epage><pages>1048-1056</pages><issn>0269-3879</issn><eissn>1099-0801</eissn><abstract>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 &amp; Sons, Ltd.</abstract><cop>England</cop><pub>Blackwell Publishing Ltd</pub><pmid>24424850</pmid><doi>10.1002/bmc.3114</doi><tpages>9</tpages></addata></record>
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subjects Acetates - blood
Acetates - chemistry
Acetates - pharmacokinetics
Adult
bioequivalence
Chromatography, High Pressure Liquid - methods
Cross-Over Studies
Drug Stability
fexofenadine
human plasma
Humans
LC-MS/MS
Linear Models
Male
method validation
montelukast
pharmacokinetics
Quinolines - blood
Quinolines - chemistry
Quinolines - pharmacokinetics
Reproducibility of Results
Sensitivity and Specificity
Single-Blind Method
Spectrometry, Mass, Electrospray Ionization - methods
Tandem Mass Spectrometry - methods
Terfenadine - analogs & derivatives
Terfenadine - blood
Terfenadine - chemistry
Terfenadine - pharmacokinetics
Therapeutic Equivalency
title Sensitive LC-MS/MS-ESI method for simultaneous determination of montelukast and fexofenadine in human plasma: application to a bioequivalence study
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