title: [Determination of Desloratadine and Its Metabolite 3-OH Desloratadine in Human Plasma by LC-MS/MS].
abstract: OBJECTIVE
  To develop a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the simultaneous determination of desloratadine and its metabolite 3-OH desloratadine in human plasma.
  
  
  METHODS
  24 healthy male volunteers received a single oral dose of 5 mg desloratadine tablets in a randomized crossover bioequivalence study with two preparations of tablets. Serial plasma samples were taken and analyzed by the LC-MS/MS method. The pharmacokinetic parameters of the two preparations were calculated and compared statistically to evaluate their bioequivalence using Winnonlin 6. 3.
  
  
  RESULTS
  The calibration curves of desloratadine and 3-OH desloratadine were both linear over the concentration range of 0. 050-6. 0 ng/mL, with intra-batch and inter-batch relative standard deviations less than 15%. The 90% confidence intervals (CIs) of peak concentration (Cmax) area under the curve (AUC)0t and AUC0-∞ of desloratadine and 3-OH desloratadine all resided within the bioequivalence limit 80%-125%. No significant difference in peak time (Tmax) was demonstrated between the two preparations.
  
  
  CONCLUSIONS
  The LC-MS/MS method can be used for simultaneous determination of desloratadine and 3-OH desloratadine in human plasma, which has been successfully applied-to a bioequivalence study.
authors.forename: Kun
authors.initials: K
authors.lastname: Zhang
authors.forename: Xi-qian
authors.initials: XQ
authors.lastname: Zhang
authors.forename: Wei
authors.initials: W
authors.lastname: Lu
authors.forename: Hui-ru
authors.initials: HR
authors.lastname: Xie
authors.forename: Lin
authors.initials: L
authors.lastname: He
authors.forename: Xue-hua
authors.initials: XH
authors.lastname: Jiang
authors.forename: Ling
authors.initials: L
authors.lastname: Wang
mesh_terms: D019540:Area Under Curve; D002853:Chromatography, Liquid; D018592:Cross-Over Studies; D006801:Humans; D017336:Loratadine / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics; D008297:Male; D013607:Tablets; D053719:Tandem Mass Spectrometry; D013810:Therapeutic Equivalency
chemical_list: D013607:Tablets; D017336:Loratadine; C121345:desloratadine