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Development and validation of bioanalytical methods for imidafenacin (KRP-197/ONO-8025) and its metabolites in human urine by using liquid chromatography-tandem mass spectrometry.

Abstract
New bioanalytical methods have been developed for the determination of imidafenacin (KRP-197/ONO-8025, IM), a novel antimuscarinic drug developed for the treatment of overactive bladder, and its metabolites, M-2, M-3, M-4, M-6 and M-8 (method 1), M-5 and M-9 (method 2) in human urine by using liquid chromatography-tandem mass spectrometry. In each method, the urine sample was extracted by solid-phase extraction, separated on a semi-micro high-performance liquid chromatography column using gradient elution and detected by tandem mass spectrometer with an atmospheric pressure chemical ionization or ionspray interface. Extraction recoveries of IM and metabolites were 81.4% or more. Calibration curves had good linearity in the concentration ranges 0.2-50 ng/mL for IM, M-2, M-3, M-4, M-6 and M-8 (method 1) and 1-250 ng/mL for M-5 and M-9 (method 2), respectively. The accuracy and precision in the intra-day and inter-day reproducibility tests were within +/-17.0 and 16.1% at the lowest concentrations, and within +/-12.8 and 11.1% at higher concentrations, respectively. Using these analytical methods, excretion profiles of IM and its metabolites in human urine were successfully determined after oral administration of IM at the therapeutic dosage of 0.1 mg.
AuthorsYuichi Masuda, Norihiro Kanayama, Shigeru Manita, Satoshi Ohmori, Tsuyoshi Ooie
JournalBiomedical chromatography : BMC (Biomed Chromatogr) Vol. 21 Issue 9 Pg. 940-8 (Sep 2007) ISSN: 0269-3879 [Print] England
PMID17474137 (Publication Type: Journal Article, Validation Study)
CopyrightCopyright (c) 2007 John Wiley & Sons, Ltd.
Chemical References
  • Imidazoles
  • imidafenacin
Topics
  • Administration, Oral
  • Calibration
  • Chromatography, Liquid (methods)
  • Humans
  • Imidazoles (administration & dosage, urine)
  • Male
  • Reference Standards
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Tandem Mass Spectrometry (methods)

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