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Type: Artigo de periódico
Title: Meloxicam determination in human plasma by high-performance liquid chromatography coupled with tandem mass spectrometry (LC-MS-MS) in Brazilian bioequivalence studies
Author: Rigato, HM
Mendes, GD
Borges, NCD
Moreno, RA
Abstract: Objective: 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.
Subject: meloxicam
high-performance liquid chromatography
tandem mass spectrometry (LC-MS-MS)
Country: Alemanha
Editor: Dustri-verlag Dr Karl Feistle
Rights: fechado
Date Issue: 2006
Appears in Collections:Unicamp - Artigos e Outros Documentos

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