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Validation and application of an automated 96 -well solid-phase extraction liquid chromatography-tandem mass spectrometry method for the quantitative determination of SCH 201781 in human plasma.

Abstract
SCH 201781 is a direct thrombin inhibitor recently under study in clinical trials to determine its safety and efficacy for the treatment of venous and arterial thrombosis. In aqueous solution, SCH 201781 exists as three forms, a ring-opened hydrated form and two ring-closed diastereomers. An automated solid-phase extraction LC-MS/MS method that chromatographically separates and measures each form was developed and validated from 1 to 1000 ng/mL in human plasma. For calibration curve standards, within- and between-run precision (%CV) ranged from 0.6 to 13.7%, while accuracy (%bias) ranged from -4.8 to 13.1%. For quality control samples, within- and between-run %CV ranged from 1.5 to 9.9% while %bias ranged from -9.1 to 4.9%. The method requires a sample volume of 0.8 ml and utilizes 2H6-labeled SCH 201781 as the internal standard. For sample processing, an Isolute C-8 96-well solid phase extraction plate and a Tomtec Quadra 96 sample processor is employed. Separation of the three forms of SCH 201781 is achieved using a 5 microm, 2 mm x 100 mm Asahipak C8 HPLC column and gradient elution. A Sciex API 365 equipped with a turbo ionspray source is used in the selected reaction monitoring mode for detection. The validated method was used to support clinical studies.
AuthorsLiyu Yang, Ning Wu, Geoffrey S Rule, Dale A Campbell, John R Perkins, Patrick J Rudewicz
JournalJournal of chromatography. B, Analytical technologies in the biomedical and life sciences (J Chromatogr B Analyt Technol Biomed Life Sci) Vol. 809 Issue 1 Pg. 75-80 (Sep 25 2004) ISSN: 1570-0232 [Print] Netherlands
PMID15354313 (Publication Type: Journal Article, Validation Study)
Chemical References
  • Antithrombins
  • Piperidines
  • SCH 201781
  • Sulfonamides
Topics
  • Antithrombins (analysis)
  • Automation
  • Calibration
  • Chromatography, Liquid (methods)
  • Humans
  • Mass Spectrometry (methods)
  • Piperidines (blood)
  • Reference Standards
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Sulfonamides (blood)

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