title: Development and validation of a liquid chromatography-tandem mass spectrometry method to determine ulifloxacin, the active metabolite of prulifloxacin in rat and rabbit plasma: application to toxicokinetic study.
abstract: A simple, high-throughput and specific high-performance liquid chromatography-tandem mass spectrometry method has been developed and validated according to the FDA guidelines for quantification of ulifloxacin in rat and rabbit plasma. The analyte was separated on a Peerless basic C(18) column (33 × 4.6 mm, 3 µm) with an isocratic mobile phase of methanol-water containing formic acid (0.5%, v/v; 9:1, v/v) at a flow rate of 0.5 mL/min. The MS/MS detection was carried out by monitoring the fragmentation of m/z 350.500 → 248.500 for ulifloxacin and m/z 332.400 → 231.400 for ciprofloxacin (internal standard; IS) on a triple quadrupole mass spectrometer. The response to ulifloxacin was linear over the range 0.010-2.500 µg/mL in both plasma. The limit of detection and lower limit of quantification of ulifloxacin were determined in both species to be 0.0025 and 0.010 µg/mL, respectively. The method was successfully applied to quantitatively assess the toxicokinetics of ulifloxacin in rat and rabbit following a single 400 mg/kg (in rat) and 200 mg/kg (in rabbit) oral dose of the prulifloxacin.
authors.affiliation: Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata-700032, India.
authors.forename: Bikash
authors.initials: B
authors.lastname: Roy
authors.forename: Hira
authors.initials: H
authors.lastname: Choudhury
authors.forename: Ayan
authors.initials: A
authors.lastname: Das
authors.forename: Anjan Kumar
authors.initials: AK
authors.lastname: Das
authors.forename: Tapan Kumar
authors.initials: TK
authors.lastname: Pal
mesh_terms: D000818:Animals; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004148:Dioxolanes / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics / Q000633:toxicity; D004355:Drug Stability; D024841:Fluoroquinolones / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics / Q000633:toxicity; D016014:Linear Models; D008297:Male; D010879:Piperazines / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics / Q000633:toxicity; D011817:Rabbits; D051381:Rats; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D053719:Tandem Mass Spectrometry / Q000379:methods*
chemical_list: D004148:Dioxolanes; D024841:Fluoroquinolones; D010879:Piperazines; C074190:ulifloxacin; C074191:prulifloxacin