title: A simple LC-MS/MS method for determination of sitafloxacin in human urine.
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.
authors.affiliation: Department of Pharmacy, The First Affiliated Hospital with Nanjing Medical University, 300 Guangzhou Road, Nanjing 210029, PR China.
authors.forename: Yuanyuan
authors.initials: Y
authors.lastname: Wang
authors.affiliation: School of Pharmacy, Nanjing Medical University, 140 Hanzhong Road, Nanjing 210029, PR China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Department of Pharmacy, The First Affiliated Hospital with Nanjing Medical University, 300 Guangzhou Road, Nanjing 210029, PR China. Electronic address: 1625741000@qq.com.
authors.forename: Hongwen
authors.initials: H
authors.lastname: Zhang
authors.affiliation: Department of Pharmacy, The First Affiliated Hospital with Nanjing Medical University, 300 Guangzhou Road, Nanjing 210029, PR China.
authors.forename: Yongqing
authors.initials: Y
authors.lastname: Wang
authors.affiliation: Department of Pharmacy, The First Affiliated Hospital with Nanjing Medical University, 300 Guangzhou Road, Nanjing 210029, PR China.
authors.forename: Yun
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Department of Pharmacy, The First Affiliated Hospital with Nanjing Medical University, 300 Guangzhou Road, Nanjing 210029, PR China.
authors.forename: Libin
authors.initials: L
authors.lastname: Wang
authors.affiliation: Department of Pharmacy, The First Affiliated Hospital with Nanjing Medical University, 300 Guangzhou Road, Nanjing 210029, PR China. Electronic address: ningou_jsph@sina.com.
authors.forename: Ning
authors.initials: N
authors.lastname: Ou
mesh_terms: D000328:Adult; D002853:Chromatography, Liquid / Q000379:methods*; D004355:Drug Stability; D005260:Female; D024841:Fluoroquinolones / Q000737:chemistry / Q000493:pharmacokinetics / Q000652:urine*; D006801:Humans; D016014:Linear Models; D008297:Male; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D053719:Tandem Mass Spectrometry / Q000379:methods*
chemical_list: D024841:Fluoroquinolones; C076246:sitafloxacin
keywords: LC–MS/MS; Sitafloxacin; Urine; Urine recovery study