Budesonide quantification by HPLC coupled to atmospheric pressure photoionization (APPI) tandem mass spectrometry. Application to a comparative systemic bioavailability of two budesonide formulations in healthy volunteers

dc.creatorBorges, NCD
dc.creatorAstigarraga, RB
dc.creatorSverdloff, CE
dc.creatorBorges, BC
dc.creatorPaiva, TR
dc.creatorGalvinas, PR
dc.creatorMoreno, RA
dc.date2011
dc.dateFEB 1
dc.date2014-07-30T17:00:17Z
dc.date2015-11-26T16:29:34Z
dc.date2014-07-30T17:00:17Z
dc.date2015-11-26T16:29:34Z
dc.date.accessioned2018-03-28T23:10:38Z
dc.date.available2018-03-28T23:10:38Z
dc.identifierJournal Of Chromatography B-analytical Technologies In The Biomedical And Life Sciences. Elsevier Science Bv, v. 879, n. 41732, n. 236, n. 242, 2011.
dc.identifier1570-0232
dc.identifierWOS:000287269800002
dc.identifier10.1016/j.jchromb.2010.12.003
dc.identifierhttp://www.repositorio.unicamp.br/jspui/handle/REPOSIP/63295
dc.identifierhttp://repositorio.unicamp.br/jspui/handle/REPOSIP/63295
dc.identifier.urihttp://repositorioslatinoamericanos.uchile.cl/handle/2250/1269756
dc.descriptionIn the present study, a novel, fast, sensitive and robust method to quantify budesonide in human plasma using 3-keto-desogestrel as the internal standard (IS) is described. The analyte and the IS were extracted from human plasma by liquid-liquid extraction (LLE) using ether. Extracted samples were analyzed by high performance liquid chromatography coupled to Atmospheric pressure photoionization tandem mass spectrometry (HPLC-APPI-MS/MS). Chromatography was performed isocratically on a C18, 5 mu m analytical column. The temperature of the autosampler was kept at 6 degrees C and the run time was 4.00 min. A linear calibration curve over the range 7.5-1000 pg ml(-1) was obtained and the lowest concentration quantified was 7.5 pg ml(-1), demonstrating acceptable accuracy and precision. This analytical method was applied in a relative bioavailability study in order to compare a test budesonide 64 mu g/dose nasal spray formulation vs. a reference 64 mu g/dose nasal spray formulation (Budecort Aqua) in 48 volunteers of both sexes. The study was conducted in an open randomized two-period crossover design and with a one-week washout period. Plasma samples were obtained over a 14h interval. Since the 90% CI for both C(max), AUC(last) and AUC(0-inf) were within the 80-125% interval proposed by the Food and Drug Administration and ANVISA, it was concluded that budesonide 64 mu g/dose nasal spray was bioequivalent to Budecort Acqua (R) 64 mu g/dose nasal spray, according to both the rate and extent of absorption. (C) 2010 Elsevier B.V. All rights reserved.
dc.description879
dc.description41732
dc.description236
dc.description242
dc.languageen
dc.publisherElsevier Science Bv
dc.publisherAmsterdam
dc.publisherHolanda
dc.relationJournal Of Chromatography B-analytical Technologies In The Biomedical And Life Sciences
dc.relationJ. Chromatogr. B
dc.rightsfechado
dc.rightshttp://www.elsevier.com/about/open-access/open-access-policies/article-posting-policy
dc.sourceWeb of Science
dc.subjectBudesonide
dc.subjectNasal spray
dc.subjectAllergy
dc.subjectLC-MS/MS
dc.subjectBioavailability
dc.subjectPharmacokinetics
dc.subjectLiquid-chromatography
dc.subjectElectrospray-ionization
dc.subjectPlasma Samples
dc.subjectPharmacokinetics
dc.subjectCorticosteroids
dc.subjectPharmacodynamics
dc.subjectAvailability
dc.subjectInhalation
dc.subjectRhinitis
dc.subjectChildren
dc.titleBudesonide quantification by HPLC coupled to atmospheric pressure photoionization (APPI) tandem mass spectrometry. Application to a comparative systemic bioavailability of two budesonide formulations in healthy volunteers
dc.typeArtículos de revistas


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