alexa UPLC MS MS assay for routine quantification of dabigatran - a direct thrombin inhibitor - in human plasma.
Chemical Engineering

Chemical Engineering

Journal of Chromatography & Separation Techniques

Author(s): Delavenne X, Moracchini J, Laporte S, Mismetti P, Basset T

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Abstract This article described the development and full validation of rapid and accurate liquid chromatography method, coupled with tandem mass spectrometry detection, for quantification of dabigatran in human plasma with [(13)C(6)]-dabigatran as internal standard. Plasma pretreatment involved a single step protein precipitation with methanol. Separation was performed by ultra performance reversed-phase chromatography on an Acquity UPLC BEH C8 100 mm × 1 mm × 1.7 μm column using a gradient elution mode. The mobile phase was a mix of distilled water containing 0.1\% formic acid and methanol containing 0.1\% formic acid. Specific multiple reaction monitoring transitions were recorded in positive electrospray ionization. The method was linear over the concentration range of 2-500 μg/L. The intra- and inter-day precision values were below 11.3\% and accuracy was within 93.8\% and 108.8\% for all QC levels (5, 75 and 400 μg/L). The lower limit of quantification was 2 μg/L. Total analysis time was to 10 min including sample preparation. Copyright © 2011 Elsevier B.V. All rights reserved. This article was published in J Pharm Biomed Anal and referenced in Journal of Chromatography & Separation Techniques

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