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Determination Of Purulifloxacin In Biological Specimen And Clinical Pharmacokinetic Study Of Pazufloxacin Monomethanesulfonate

Posted on:2007-12-31Degree:MasterType:Thesis
Country:ChinaCandidate:L X GuoFull Text:PDF
GTID:2144360185988717Subject:Drug Analysis
Abstract/Summary:PDF Full Text Request
Two convenient HPLC-UV method and a specific and rapid LC/MS/MS methods were developed to determine two quinolones antibacterial agent levels in human plasma and urine, respectively.The methods were successfully used in pharmacokinetic studies.Determination of prulifloxacin in human plasma and urine by high-performance liquid chromatographyPrulifloxacin is rapidly de-esterified after absorption to yield its active metabolite, NM 394.So a sensitive and specific high-performance liquid chromatographic method was developed for the determination of NM 394 levels in human plasma and urine.Sample preparation involved derivatization and extraction with dichlormethane (contain 1% ethyl chorformate, v/v) .NM 394 and the internal standard, norfloxacin, were separated on a Diamonsil C18 column, using a mobile phase of methanol-0.05 mol/L ammonium dihydrogen phosphate buffer (50: 80, v/v) at a flow-rate of 1.5 mL/min, with the detection wavelength at 275 nm.The linear calibration curve of plasma was obtained in the concentration range of 0.1-5.0 μg/mL and the linear calibration curve of urine was obtained in the concentration range of 0.5-100.0 μg/mL.The main pharmacokinetics parameter of 12 healthy volunteers after oral administration of 200 mg and 300 mg of prulifloxacin. Mean peak plasma levels (Cmax) was 2.43 and 3.65 μg/mL , the mean Tmax was 1.08 and 1.17 h , the mean t1/2 value was 10.91 and 18.35 h, the mean AUC0-t was 10.38 and 16.78 μg·h/mL, respectively.About 38% prulifloxacin was excreted in urine via kidney of NM 394 form within 72 h after oral administration.Determination of prulifloxacin in human plasma by liquid chromatography-tandem mass spectrometryNM 394, the active metabolite of prulifloxacin can not be separated from endogenous compounds with routine chromatographic condition due to its great polarity and amphiprotic...
Keywords/Search Tags:prulifloxacin, NM 394, pazufloxacin monomethanesulfonate, high-performance liquid chromatography, liquid chromatography- tandem mass spectrometry, pharmacokinetics
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