title: Determination of sitafloxacin in human plasma by liquid chromatography-tandem mass spectrometry method: application to a pharmacokinetic study.
abstract: A high-performance liquid chromatographic-tandem mass spectrometric (HPLC-MS/MS) method was developed and validated to determine sitafloxacin in human plasma with dextrorphan as internal standard. Chromatographic separation was performed on a ZORBAX SB-C18 column (3.5μm, 2.1mm×100mm) with the mobile phase of methanol/water (containing 0.1% formic acid) (46:54, v/v) at a flow rate of 0.2mL/min. Quantification was performed using multiple-reaction monitoring of the transitions at m/z 410.2 → 392.2 for sitafloxacin and m/z 258.1 → 157.1 for dextrorphan, respectively. The calibration curve was linear over the range of 5-2500ng/mL with the lower limit of quantification of 5ng/mL for sitafloxacin. The intra- and inter-day precisions were less than 8.3% and the deviations of assay accuracies were within ±4.1%. Sitafloxacin was sufficiently stable under all relevant analytical conditions. This method was successfully applied to the pharmacokinetic study of sitafloxacin in healthy Chinese volunteers.
authors.affiliation: Drug Clinical Trial Institution, Wuxi People' Hospital, Nanjing Medical University, Wuxi 214023, China.
authors.forename: Kai
authors.initials: K
authors.lastname: Huang
authors.affiliation: Drug Clinical Trial Institution, Wuxi People' Hospital, Nanjing Medical University, Wuxi 214023, China.
authors.forename: Jie
authors.initials: J
authors.lastname: Yang
authors.affiliation: Drug Clinical Trial Institution, Wuxi People' Hospital, Nanjing Medical University, Wuxi 214023, China.
authors.forename: Jing
authors.initials: J
authors.lastname: Zhang
authors.affiliation: Drug Clinical Trial Institution, Wuxi People' Hospital, Nanjing Medical University, Wuxi 214023, China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Ding
authors.affiliation: Drug Clinical Trial Institution, Wuxi People' Hospital, Nanjing Medical University, Wuxi 214023, China.
authors.forename: Lan
authors.initials: L
authors.lastname: Chen
authors.affiliation: Drug Clinical Trial Institution, Wuxi People' Hospital, Nanjing Medical University, Wuxi 214023, China.
authors.forename: Wen-Yan
authors.initials: WY
authors.lastname: Xu
authors.affiliation: Drug Clinical Trial Institution, Wuxi People' Hospital, Nanjing Medical University, Wuxi 214023, China.
authors.forename: Xue-Jiao
authors.initials: XJ
authors.lastname: Xu
authors.affiliation: Drug Clinical Trial Institution, Wuxi People' Hospital, Nanjing Medical University, Wuxi 214023, China.
authors.forename: Ru
authors.initials: R
authors.lastname: Duan
authors.affiliation: Drug Clinical Trial Institution, Wuxi People' Hospital, Nanjing Medical University, Wuxi 214023, China. Electronic address: najang@126.com.
authors.forename: Qing
authors.initials: Q
authors.lastname: He
mesh_terms: D000328:Adult; D002853:Chromatography, Liquid / Q000379:methods*; D004355:Drug Stability; D005260:Female; D024841:Fluoroquinolones / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics; D006801:Humans; D057230:Limit of Detection; D016014:Linear Models; D008297:Male; D015203:Reproducibility of Results; D053719:Tandem Mass Spectrometry / Q000379:methods*; D055815:Young Adult
chemical_list: D024841:Fluoroquinolones; C076246:sitafloxacin
keywords: LC–MS/MS; Pharmacokinetics; Plasma concentration; Sitafloxacin