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UPLC MS/MS assay for routine quantification of dabigatran - a direct thrombin inhibitor - in human plasma.
J Pharm Biomed Anal. 2012 Jan 25; 58:152-6.JP

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.

Authors+Show Affiliations

Laboratory of Pharmacology and Toxicology, University Hospital, F-42055 Saint-Etienne, France. xavier.delavenne@chu-st-etienne.frNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

21996066

Citation

Delavenne, Xavier, et al. "UPLC MS/MS Assay for Routine Quantification of Dabigatran - a Direct Thrombin Inhibitor - in Human Plasma." Journal of Pharmaceutical and Biomedical Analysis, vol. 58, 2012, pp. 152-6.
Delavenne X, Moracchini J, Laporte S, et al. UPLC MS/MS assay for routine quantification of dabigatran - a direct thrombin inhibitor - in human plasma. J Pharm Biomed Anal. 2012;58:152-6.
Delavenne, X., Moracchini, J., Laporte, S., Mismetti, P., & Basset, T. (2012). UPLC MS/MS assay for routine quantification of dabigatran - a direct thrombin inhibitor - in human plasma. Journal of Pharmaceutical and Biomedical Analysis, 58, 152-6. https://doi.org/10.1016/j.jpba.2011.09.018
Delavenne X, et al. UPLC MS/MS Assay for Routine Quantification of Dabigatran - a Direct Thrombin Inhibitor - in Human Plasma. J Pharm Biomed Anal. 2012 Jan 25;58:152-6. PubMed PMID: 21996066.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - UPLC MS/MS assay for routine quantification of dabigatran - a direct thrombin inhibitor - in human plasma. AU - Delavenne,Xavier, AU - Moracchini,Julie, AU - Laporte,Silvy, AU - Mismetti,Patrick, AU - Basset,Thierry, Y1 - 2011/09/22/ PY - 2011/06/21/received PY - 2011/08/17/revised PY - 2011/09/18/accepted PY - 2011/10/15/entrez PY - 2011/10/15/pubmed PY - 2012/5/23/medline SP - 152 EP - 6 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 58 N2 - 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. SN - 1873-264X UR - https://www.unboundmedicine.com/medline/citation/21996066/UPLC_MS/MS_assay_for_routine_quantification_of_dabigatran___a_direct_thrombin_inhibitor___in_human_plasma_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0731-7085(11)00536-X DB - PRIME DP - Unbound Medicine ER -