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Type: Artigo de periódico
Title: Amlodipine Bioequivalence Study: Quantification By Liquid Chromatography Coupled To Tandem Mass Spectrometry.
Author: Carvalho, M
Oliveira, C H
Mendes, G D
Sucupira, M
Moraes, M E
De Nucci, G
Abstract: To assess the bioequivalence of two amlodipine tablet formulations (Amlodipine 5 mg tablet from Merck S.A. Indústrias Químicas, Brazil as test formulation and Norvasc 5 mg tablet from Laboratórios Pfizer Ltd., Brazil as reference formulation) in 24 healthy volunteers of both sexes. 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 amlodipine 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. 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). Since the 90% CI 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 5 mg tablet (test formulation) was bioequivalent to Norvasc 5 mg tablet, in terms of both rate and extent of absorption.
Subject: Adolescent
Antihypertensive Agents
Chemistry, Pharmaceutical
Chromatography, High Pressure Liquid
Confidence Intervals
Cross-over Studies
Linear Models
Mass Spectrometry
Therapeutic Equivalency
Rights: fechado
Identifier DOI: 
Date Issue: 2001
Appears in Collections:Artigos e Materiais de Revistas Científicas - Unicamp

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