title: Determination of trimebutine and desmethyl-trimebutine in human plasma by HPLC.
abstract: A simple and sensitive HPLC method has been developed to measure trimebutine (CAS 39133-31-8, maleate: CAS 34140-59-5) and its main metabolite desmethyl-trimebutine in human plasma. The method was validated according to the Washington Consensus Conference on the Validation of Analytical Methods. It involved extraction of the plasma with n-hexane containing 2-pentanol, followed by reversed-phase HPLC using a Partisil ODS2 10 microns column and UV detection at 265 nm. The retention times of the internal standard (procaine), desmethyl-trimebutine and trimebutine were 2.4, 4.3 and 6.5 min, respectively. The standard curves were linear from 20 ng.ml-1 (limit of quantitation) to 5000 ng.ml-1 for both compounds. The coefficient of variation for all the criteria of validation were less than 15%. The extraction recoveries obtained for trimebutine and desmethyl-trimebutine were about 90%. Both compounds were very stable upon storage in plasma. The method was tested by measuring the plasma concentrations following oral administration to humans during a bioequivalence study and was shown suitable for pharmacokinetic studies.
authors.affiliation: Laboratoire de Pharmacocinétique et de Toxicologie Clinique, Centre Hospitalier Universitaire, Toulouse, France.
authors.forename: M
authors.initials: M
authors.lastname: Lavit
authors.forename: S
authors.initials: S
authors.lastname: Saivin
authors.forename: H
authors.initials: H
authors.lastname: Boudra
authors.forename: F
authors.initials: F
authors.lastname: Michel
authors.forename: A
authors.initials: A
authors.lastname: Martin
authors.forename: G
authors.initials: G
authors.lastname: Cahiez
authors.forename: J P
authors.initials: JP
authors.lastname: Labaune
authors.forename: J M
authors.initials: JM
authors.lastname: Chomard
authors.forename: G
authors.initials: G
authors.lastname: Houin
mesh_terms: D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D005765:Gastrointestinal Agents / Q000097:blood*; D006801:Humans; D007202:Indicators and Reagents; D011786:Quality Control; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet; D013810:Therapeutic Equivalency; D014287:Trimebutine / Q000031:analogs & derivatives* / Q000097:blood
chemical_list: D005765:Gastrointestinal Agents; D007202:Indicators and Reagents; C053065:N-desmethyltrimebutine; D014287:Trimebutine