Meloxicam determination in human plasma by high-performance liquid chromatography coupled with tandem mass spectrometry (LC-MS-MS) in Brazilian bioequivalence studies

dc.creatorRigato, HM
dc.creatorMendes, GD
dc.creatorBorges, NCD
dc.creatorMoreno, RA
dc.date2006
dc.dateOCT
dc.date2014-11-19T23:10:02Z
dc.date2015-11-26T18:06:55Z
dc.date2014-11-19T23:10:02Z
dc.date2015-11-26T18:06:55Z
dc.date.accessioned2018-03-29T00:49:04Z
dc.date.available2018-03-29T00:49:04Z
dc.identifierInternational Journal Of Clinical Pharmacology And Therapeutics. Dustri-verlag Dr Karl Feistle, v. 44, n. 10, n. 489, n. 498, 2006.
dc.identifier0946-1965
dc.identifierWOS:000241128000006
dc.identifierhttp://www.repositorio.unicamp.br/jspui/handle/REPOSIP/53577
dc.identifierhttp://www.repositorio.unicamp.br/handle/REPOSIP/53577
dc.identifierhttp://repositorio.unicamp.br/jspui/handle/REPOSIP/53577
dc.identifier.urihttp://repositorioslatinoamericanos.uchile.cl/handle/2250/1293466
dc.descriptionObjective: In this study, the bioavailability of 2 meloxicam 15 mg tablet formulations was compared. A single dose of each formulation was administered to 24 healthy volunteers (12 males and 12 females). Material and methods: The study was conducted using an open, randomized and crossover design with a 2-week washout interval. The plasma samples were obtained over a 96-hour interval and meloxicam concentrations were analyzed by high-performance liquid chromatography (an agilent) coupled to an API 2000 turboionspray tandem mass spectrometry (LC-MS-MS). An electrospray ionization (ESI) source operating in the positive ion mode, using a cross flow counter electrode and set for the multiple reaction monitoring (MRM) was employed. The plasma protein precipitate was reconstituted with acetonitrile/water + 10 mM acetic acid (20/80, v/v) and injected in a Prevail C-8 5 mu m (150 mm x 4.6 mm i.d.) analytical column with reverse-phase liquid chromatography. The retention time observed for meloxicam and tenoxicam (internal standard) was 1.8 and 1.4 minutes, respectively. The mean recovery of meloxicam was 95.9% and the limit of quantification was 0.02 mu g/ml. Results: The geometric mean of meloxicam/movatec 15 mg individual % ratio was 101.3% for AUC(last), 99.9% for AUC0(-infinity) and 107.7% for C-max, The 90% confidence intervals were 97.3 - 105.4%, 96.0 - 104.0% and 98.8 - 117.4%, respectively. Conclusion: Since the 90% Cl for both AUC(last), AUC(0-infinity), and C-max, ratios were all inside the 80 - 125% interval proposed by the US Food and Drug Administration Agency and accepted by Brazilian ANVISA (Sanitary Surveillance Agency), it was concluded that the meloxicarn formulation produced by Merck S.A. Industrias Quimicas is bioequivalent to the movatec formulation regarding both the rate and extent of absorption. This assay method was faster, more simple, specific, precise and accurate in determining the bioequivalence of meloxicam than any method previously described.
dc.description44
dc.description10
dc.description489
dc.description498
dc.languageen
dc.publisherDustri-verlag Dr Karl Feistle
dc.publisherDeisenhofen-muenchen
dc.publisherAlemanha
dc.relationInternational Journal Of Clinical Pharmacology And Therapeutics
dc.relationInt. J. Clin. Pharmacol. Ther.
dc.rightsfechado
dc.sourceWeb of Science
dc.subjectmeloxicam
dc.subjectbioequivalence
dc.subjecthigh-performance liquid chromatography
dc.subjecttandem mass spectrometry (LC-MS-MS)
dc.subjectGastrointestinal Tolerability
dc.subjectCyclooxygenase
dc.subjectPharmacokinetics
dc.subjectOsteoarthritis
dc.subjectInhibition
dc.subjectEfficacy
dc.subjectTrial
dc.titleMeloxicam determination in human plasma by high-performance liquid chromatography coupled with tandem mass spectrometry (LC-MS-MS) in Brazilian bioequivalence studies
dc.typeArtículos de revistas


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