Rapid and sensitive LC-MS/MS method for quantification of lamotrigine in human plasma: application to a human pharmacokinetic study

ABSTRACT A highly sensitive, specific and fully validated LC‐MS/MS method as per general practices of industry has been developed for estimation of lamotrigine (LAM) with 100 μL of human plasma using flucanozole as an internal standard (IS). The API‐4000 LC‐MS/MS was operated under the multiple reac...

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Bibliographic Details
Published in:	Biomedical chromatography Vol. 26; no. 4; pp. 491 - 496
Main Authors:	Hotha, Kishore Kumar, Kumar, S.Sirish, Bharathi, D. Vijaya, Venkateswarulu, V.
Format:	Journal Article
Language:	English
Published:	Chichester, UK John Wiley & Sons, Ltd 01-04-2012
Subjects:	Anticonvulsants - blood Chromatography, Liquid - economics Chromatography, Liquid - methods Humans LAM lamotrigine LC-MS/MS Liquid-Liquid Extraction - methods Male method validation pharmacokinetics Sensitivity and Specificity Tandem Mass Spectrometry - economics Tandem Mass Spectrometry - methods Time Factors Triazines - blood
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Summary:	ABSTRACT A highly sensitive, specific and fully validated LC‐MS/MS method as per general practices of industry has been developed for estimation of lamotrigine (LAM) with 100 μL of human plasma using flucanozole as an internal standard (IS). The API‐4000 LC‐MS/MS was operated under the multiple reaction‐monitoring mode using electrospray ionization. A simple liquid–liquid extraction process was used to extract LAM and IS from human plasma. The total run time was 2.0 min and the elution of LAM and IS occurred at 1.25 and 1.45 min; this was achieved with a mobile phase consisting of 0.1% formic acid–methanol (20:40:40, v/v) at a flow rate of 0.50 mL/min on a Discovery CN (50 × 4.6 mm, 5 µm) column. The developed method was validated in human plasma with a lower limit of quantitation of 0.1 ng/mL for LAM. A linear response function was established for the range of concentrations 0.1–1500 ng/mL (r > 0.998) for LAM. The intra‐ and inter‐day precision values for LAM met the acceptance as per Food and Drug Administration guidelines. LAM was stable in the set of stability studies, viz. bench‐top, autosampler and freeze–thaw cycles. The developed assay method was applied to an oral bioequivalence study in humans. Copyright © 2011 John Wiley & Sons, Ltd.
Bibliography:	istex:7B5E4F41E2170368BEE1C05316E8A6FF199D9E59 ark:/67375/WNG-8NVG88X2-0 ArticleID:BMC1692 ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0269-3879 1099-0801
DOI:	10.1002/bmc.1692