A Bioequivalence Study Of Citalopram Based On Quantification By High-performance Liquid Chromatography Coupled To Electrospray Tandem Mass Spectrometry.

dc.creatorMendes, G Duarte
dc.creatorBorges, N Carter do Carmo
dc.creatorPereira, A dos Santos
dc.creatorMendes, F Duarte
dc.creatorBarrientos-Astigarraga, R Eliseo
dc.creatorDe Nucci, G
dc.date2005-Aug
dc.date2015-11-27T13:02:22Z
dc.date2015-11-27T13:02:22Z
dc.date.accessioned2018-03-29T01:01:18Z
dc.date.available2018-03-29T01:01:18Z
dc.identifierInternational Journal Of Clinical Pharmacology And Therapeutics. v. 43, n. 8, p. 389-98, 2005-Aug.
dc.identifier0946-1965
dc.identifier
dc.identifierhttp://www.ncbi.nlm.nih.gov/pubmed/16119514
dc.identifierhttp://repositorio.unicamp.br/jspui/handle/REPOSIP/196383
dc.identifier16119514
dc.identifier.urihttp://repositorioslatinoamericanos.uchile.cl/handle/2250/1296616
dc.descriptionThe aim of this study was to compare the bioavailability of two citalopram formulations (citalopram from Eurofarma Laboratórios Ltda., as the test formulation, and cipramil from Schering-Plough, Brazil, as the reference formulation) in healthy volunteers. The study had an open, randomized, two-period crossover design with a two-week washout interval between doses. The samples were obtained over a 168-hour interval after each oral administration of citalopram (one 20 mg tablet of each formulation). The analyte and the internal standard were extracted from plasma using diethylether: dichloromethane (70 : 30, v/v) and the extracts were analyzed by high-performance liquid chromatography coupled to electrospray tandem mass spectrometry. Chromatography was done isocratically using a Genesis C8 analytical column (4 microm, 2.1 mm i.d. x 100 mm). The method had a chromatographic run time of three minutes and a linear calibration curve over the range of 0.5 - 200 ng x ml(-1) (r2 > 0.999887). The limit of quantification was 0.5 ng x ml(-1). The geometric mean and 90% confidence intervals (CI) for the citalopram/cipramil ratio were 98.28% (94.24 - 102.49%) for AUClast, 96.44% (90.20 - 103.11%) for AUCinf, and 98.54% (94.70 - 102.54%) for Cmax. Since the 90% CI for Cmax, AUClast and AUC(0-infinity) ratios were all within the 80 - 125% interval proposed by the US Food and Drug Administration, we concluded that the citalopram formulation elaborated by Eurofarma Laboratórios Ltda. was bioequivalent to the cipramil formulation in its rate and extent of absorption.
dc.description43
dc.description389-98
dc.languageeng
dc.relationInternational Journal Of Clinical Pharmacology And Therapeutics
dc.relationInt J Clin Pharmacol Ther
dc.rightsfechado
dc.rights
dc.sourcePubMed
dc.subjectAdministration, Oral
dc.subjectAdolescent
dc.subjectAdult
dc.subjectArea Under Curve
dc.subjectChromatography, High Pressure Liquid
dc.subjectCitalopram
dc.subjectCross-over Studies
dc.subjectFemale
dc.subjectHumans
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectSerotonin Uptake Inhibitors
dc.subjectSpectrometry, Mass, Electrospray Ionization
dc.subjectTherapeutic Equivalency
dc.titleA Bioequivalence Study Of Citalopram Based On Quantification By High-performance Liquid Chromatography Coupled To Electrospray Tandem Mass Spectrometry.
dc.typeArtículos de revistas


Este ítem pertenece a la siguiente institución