title: Quantitative analysis of tiropramide in human plasma by gas chromatography coupled to mass spectrometry for application to a bioequivalence test.
abstract: BACKGROUND
  Tiropramide is used as an antispasmodic agent. A sensitive, selective and simple gas chromatography coupled to mass spectrometry (GC/MS) was developed for quantification of tiropramide in human plasma using internal standard (ISD, (+/-) alpha-benzoylamino-4-[2-(dimethylamino) ethoxy]-N,N-dipropylbenzenepropanamide).
  
  
  METHODS
  Tiropramide and ISD were extracted from plasma by solid-liquid extraction and analyzed on a HP-5MS column with mass selective detector.
  
  
  RESULTS
  The retention times of tiropramide and ISD were approximately 9.8 and 10.2 min, respectively. The calibration curve showed good linearity in the concentration range 5-500 ng/ml (r2=0.998) for tiropramide in human plasma and showed good precision with CVs between 0.24% and 7.69%, respectively. The method was showed good accuracy with all intra-day (n=5) and inter-day (n=5) mean concentrations within 87.9-114.1% from nominal. The recovery of tiropramide and ISD were about 75.1% and 71.0% on the average, respectively. This method was successfully applied for the bioequivalence test of 2 formulations of tiropramide in 18 healthy male volunteers who received a single 100 mg dose of each formulation.
authors.affiliation: Department of Food and Nutrition, College of Human Ecology, Hanyang University, Seoul 133-791, Korea.
authors.forename: Ok Hwa
authors.initials: OH
authors.lastname: Jhee
authors.forename: Yong Cheol
authors.initials: YC
authors.lastname: Jeon
authors.forename: Ho Sun
authors.initials: HS
authors.lastname: Choi
authors.forename: Min Ho
authors.initials: MH
authors.lastname: Lee
authors.forename: Ae Son
authors.initials: AS
authors.lastname: Om
authors.forename: Joo-Won
authors.initials: JW
authors.lastname: Lee
authors.forename: Jung Wook
authors.initials: JW
authors.lastname: Hong
authors.forename: Yong Seok
authors.initials: YS
authors.lastname: Kim
authors.forename: Ju Chan
authors.initials: JC
authors.lastname: Kang
authors.forename: Yun Sik
authors.initials: YS
authors.lastname: Lee
authors.forename: Leslie M
authors.initials: LM
authors.lastname: Shaw
authors.forename: Ju Seop
authors.initials: JS
authors.lastname: Kang
mesh_terms: D000328:Adult; D019540:Area Under Curve; D002138:Calibration; D018592:Cross-Over Studies; D008401:Gas Chromatography-Mass Spectrometry / Q000379:methods*; D006801:Humans; D008297:Male; D008657:Metabolic Clearance Rate; D010276:Parasympatholytics / Q000097:blood / Q000493:pharmacokinetics / Q000592:standards; D012015:Reference Standards; D015203:Reproducibility of Results; D013810:Therapeutic Equivalency; D014443:Tyrosine / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics
chemical_list: D010276:Parasympatholytics; D014443:Tyrosine; C031173:tiropramide