title: New chiral high-performance liquid chromatographic methodology used for the pharmacokinetic evaluation of dexfenfluramine.
abstract: A new chiral high-performance liquid chromatographic (HPLC) method utilizing ultraviolet (UV) detection has been developed for determining plasma and urinary concentrations of d-fenfluramine and its major metabolite d-norfenfluramine, while being able to determine the possible presence of l-fenfluramine after oral administration of enantiopure d-fenfluramine hydrochloride. Sensitivity, stability, and specificity were enhanced by derivatizing the extracted analytes with 3,5-dinitrophenylisocyanate while utilizing a Pirkle-type chiral recognition approach. In vitro and in vivo statistical data are analogous. Overall plasma inter-assay precision was less than 7% with a minimum quantitation limit of 10 ng/ml. Overall urine inter-assay precision was also less than 7% with a minimum quantitation limit of 25 ng/ml.
authors.affiliation: Analytical Chemistry Department, Roche Biomedical Laboratories, Raritan, NJ 08869.
authors.forename: J N
authors.initials: JN
authors.lastname: Zeng
authors.forename: L
authors.initials: L
authors.lastname: Dou
authors.forename: M
authors.initials: M
authors.lastname: Duda
authors.forename: H H
authors.initials: HH
authors.lastname: Stuting
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods; D003201:Computers; D004136:Dinitrobenzenes; D005277:Fenfluramine / Q000097:blood / Q000493:pharmacokinetics* / Q000652:urine; D006801:Humans; D007202:Indicators and Reagents; D017953:Isocyanates; D009642:Norfenfluramine / Q000097:blood / Q000652:urine; D011786:Quality Control; D013056:Spectrophotometry, Ultraviolet; D013237:Stereoisomerism
chemical_list: D004136:Dinitrobenzenes; D007202:Indicators and Reagents; D017953:Isocyanates; D009642:Norfenfluramine; D005277:Fenfluramine; C068908:3,5-dinitrophenyl isocyanate