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Drug Res (Stuttg) 2014; 64(11): 617-622
DOI: 10.1055/s-0034-1366986
Original Article
© Georg Thieme Verlag KG Stuttgart · New York

Development of an LC-Tandem Mass Spectrometry Method for the Separation of Montelukast and its Application to a Pharmacokinetic Study in Humans

E. Ezzeldin
1   Drug Bioavailability Laboratory, College of Pharmacy, King Saud University, Saudi Arabia
2   Drug Bioavailability Center, National Organization for Drug Control and Research, (NODCAR), Cairo, Egypt
,
M. H. Tammam
2   Drug Bioavailability Center, National Organization for Drug Control and Research, (NODCAR), Cairo, Egypt
,
N. F. AboTalib
2   Drug Bioavailability Center, National Organization for Drug Control and Research, (NODCAR), Cairo, Egypt
› Author Affiliations
Further Information

Publication History

received 05 November 2013

accepted 10 January 2014

Publication Date:
05 February 2014 (online)

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Development of an LC-Tandem Mass Spectrometry Method for the Separation of Montelukast and its Application to a Pharmacokinetic Study in HumansDrug Res (Stuttg) 2014; 64(11): e2-e2
DOI: 10.1055/s-0034-1389948

Abstract

Accurate, precise, and sensitive LC-MS/MS assay method for the determination of montelukast (MO) in human plasma samples using gliclazide (GL) as internal standard was developed and applied in pharmacokinetics study.

MO extracted by protein precipitation using acetonitrile. Chromatographic separation was carried out using a Agilant Triple quadrupoles mass spectrometer with API source with an Agilant SB- C18 (50×4.6 mm), 1.8 µm particle size column. A mobile phase consisting of acetonitrile: 0.1% formic acid (84:16) was delivered. Calibration curves were linear in the concentration range of (10.00–800.00) ng/ml. The bioanalytical method for determination of MO was successfully applied to assess pharmacokinetics of montelukast. The LLOQ was sensitive enough for detecting terminal phase concentrations of the drug. This study showed that developed method is suitable for MO pharmacokinetic study.

Key words

montelukast - gliclazide - LC-MS/MS - pharmacokinetic
 

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