A simple LC-MS/MS method for determination of sitafloxacin in human urine

J Chromatogr B Analyt Technol Biomed Life Sci. 2014 Sep 15:967:219-24. doi: 10.1016/j.jchromb.2014.07.015. Epub 2014 Aug 1.

Abstract

Sitafloxacin is a new fluoroquinolone antimicrobial agent with high activity. In this article, we reported a simple, rapid and specific LC-MS/MS method for accurate determination of sitafloxacin concentrations in human urine from healthy volunteers in detail. A two-step dilution method for the analysis of sitafloxacin in human urine using LC coupled to positive MS/MS has been developed and validated according to US FDA guidelines and Chinese State Food and Drug Administration (CFDA) guidelines for the validation of bioanalytical methods. The method uses 50 μL of urine and covers a working range from 0.025 to 20 μg/mL with a LLOQ of 0.025 μg/mL. This new LC-MS/MS assay is sensitive and specific.

Keywords: LC–MS/MS; Sitafloxacin; Urine; Urine recovery study.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Chromatography, Liquid / methods*
  • Drug Stability
  • Female
  • Fluoroquinolones / chemistry
  • Fluoroquinolones / pharmacokinetics
  • Fluoroquinolones / urine*
  • Humans
  • Linear Models
  • Male
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Tandem Mass Spectrometry / methods*

Substances

  • Fluoroquinolones
  • sitafloxacin