Validation and implementation of a liquid chromatography/tandem mass spectrometry assay to quantitate ON 01910.Na, a mitotic progression modulator, in human plasma

Jing Li, Ming Zhao, Antonio Jimeno, Ping He, M. V. Ramana Reddy, Manuel Hidalgo, Ross C. Donehower, Michelle A. Rudek

Research output: Contribution to journalArticlepeer-review

Abstract

A reverse-phase high performance liquid chromatographic method with tandem mass spectrometry (LC-MS/MS) was developed and validated for the quantitation of ON 01910.Na, a novel synthetic benzyl styryl sulfone, in human plasma. The assay involved a simple sample preparation with acetonitrile protein precipitation. ON 01910.Na and the internal standard temazepam were separated on a Waters X-Terra™ MS C18 column with mobile phase of acetonitrile containing 0.1% formic acid /10 mM ammonium acetate (55:45, v/v) using isocratic flow at 0.2 mL/min for 5 min. The analytes were monitored by tandem-mass spectrometry with electrospray positive ionization. Two calibration curves were generated over the range of 10-2000 ng/mL and 100-20000 ng/mL. The lower limit of quantitation (LLOQ) was 10 ng/mL for ON 01910.Na in human plasma. The accuracy and within- and between-day precisions were within the acceptance criteria for bioanalytical assays. ON 01910.Na was found stable in plasma at -70 °C for at least 1 year. The method was successfully applied to characterize the plasma concentration-time profiles of ON 01910.Na in the cancer patients in the Phase I study.

Original languageEnglish (US)
Pages (from-to)198-204
Number of pages7
JournalJournal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences
Volume856
Issue number1-2
DOIs
StatePublished - Sep 1 2007

Keywords

  • High performance liquid chromatography (HPLC)
  • LC-MS/MS
  • Mass spectrometry (MS)
  • ON 01910.Na
  • Pharmacokinetics

ASJC Scopus subject areas

  • Analytical Chemistry
  • Biochemistry
  • Clinical Biochemistry
  • Cell Biology

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