Amlodipine Bioequivalence study: Quantification by liquid chromatography coupled to tandem mass spectrometry

dc.creatorCarvalho, M
dc.creatorOliveira, CH
dc.creatorMendes, GD
dc.creatorSucupira, M
dc.creatorMoraes, MEA
dc.creatorDe Nucci, G
dc.date2001
dc.dateDEC
dc.date2014-11-19T16:20:43Z
dc.date2015-11-26T17:29:56Z
dc.date2014-11-19T16:20:43Z
dc.date2015-11-26T17:29:56Z
dc.date.accessioned2018-03-29T00:16:55Z
dc.date.available2018-03-29T00:16:55Z
dc.identifierBiopharmaceutics & Drug Disposition. John Wiley & Sons Ltd, v. 22, n. 9, n. 383, n. 390, 2001.
dc.identifier0142-2782
dc.identifierWOS:000174196000002
dc.identifier10.1002/bdd.282
dc.identifierhttp://www.repositorio.unicamp.br/jspui/handle/REPOSIP/54236
dc.identifierhttp://www.repositorio.unicamp.br/handle/REPOSIP/54236
dc.identifierhttp://repositorio.unicamp.br/jspui/handle/REPOSIP/54236
dc.identifier.urihttp://repositorioslatinoamericanos.uchile.cl/handle/2250/1285402
dc.descriptionObjective-To assess the bioequivalence of two amlodipine tablet formulations (Amlodipine(R) 5 mg tablet from Merck S.A. Industrias Quimicas, Brazil as test formulation and Norvasc(R) 5 mg tablet from Laboratorios Pfizer Ltd., Brazil as reference formulation) in 24 healthy volunteers of both sexes. Methods-The study Was conducted using an open, randomized two-period crossover design with a 4-week washout interval. Plasma samples were obtained over a 144 h period. Plasma amlodipine concentrations were analyzed by combined liquid chromatography coupled to tandem mass spectrometry (LC-MS-MS) with positive ion electrospray ionization using multiple reaction monitoring (MRM). From the amiodipine plasma concentration vs time curves, the following pharmacokinetic parameters were obtained: AUC(last), AUC(0-inf) and C-max. The statistical interval proposed was 80-125% according to the US Food and Drug Administration Agency. Results-The limit of quantification was 0.1 ng/ml for plasma amlodipine analysis. The geometric mean and the 90% confidence interval (CI) test/reference ratios were 101.2 (92.9-110.2%) for AUC(last), 99.6 (91.5-108.4%) for AUC(0-inf), and 98.5 (89.0-109.1%) for C-max. Conclusion-Since the 90% Cl for AUC(last), AUC(0-inf) and C-max ratios were within in the 80-125% interval proposed by the US FDA, it was concluded that Amlodipine(R) 5 mg tablet (test formulation) was bioequivalent to Norvasc(R) 5 mg tablet, in terms of both rate and extent of absorption. Copyright (C), 2001 John Wiley Sons, Ltd.
dc.description22
dc.description9
dc.description383
dc.description390
dc.languageen
dc.publisherJohn Wiley & Sons Ltd
dc.publisherW Sussex
dc.publisherInglaterra
dc.relationBiopharmaceutics & Drug Disposition
dc.relationBiopharm. Drug Dispos.
dc.rightsfechado
dc.rightshttp://olabout.wiley.com/WileyCDA/Section/id-406071.html
dc.sourceWeb of Science
dc.subjectpharmacokinetics
dc.subjectdesipramine
dc.subjectHPLC
dc.subjectLC-MS-MS
dc.subjectS-(-)-amlodipine
dc.subjectR-(+)-amlodipine
dc.subjectPlasma
dc.titleAmlodipine Bioequivalence study: Quantification by liquid chromatography coupled to tandem mass spectrometry
dc.typeArtículos de revistas


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