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Type: Artigo de periódico
Title: 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
Author: Borges, NCD
Astigarraga, RB
Sverdloff, CE
Borges, BC
Paiva, TR
Galvinas, PR
Moreno, RA
Abstract: In 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.
Subject: Budesonide
Nasal spray
Country: Holanda
Editor: Elsevier Science Bv
Citation: Journal Of Chromatography B-analytical Technologies In The Biomedical And Life Sciences. Elsevier Science Bv, v. 879, n. 41732, n. 236, n. 242, 2011.
Rights: fechado
Identifier DOI: 10.1016/j.jchromb.2010.12.003
Date Issue: 2011
Appears in Collections:Unicamp - Artigos e Outros Documentos

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