alexa Cimetidine Quantification in Human Plasma by High-performance Liquid Chromatography Coupled to Electrospray Ionization Tandem Mass Spectrometry. Application to a Comparative Pharmacokinetics Study | Abstract
ISSN: 1948-593X

Journal of Bioanalysis & Biomedicine
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Research Article

Cimetidine Quantification in Human Plasma by High-performance Liquid Chromatography Coupled to Electrospray Ionization Tandem Mass Spectrometry. Application to a Comparative Pharmacokinetics Study

Moreno RA1,2, Oliveira CostaI3, Brum Junior L4, Sverdloff CE1,2, Domingues CC1, Borges DC5, Oliveira RA1, Borges NC1,6*

1Synchrophar Assessoria e Desenvolvimento de Projetos Clínicos, Campinas, SP, Brazil

2Department of Pharmacology, Faculty of Medical Sciences, State University of Campinas (UNICAMP), Campinas, SP, Brazil

3Department of Bioequivalence, Hermes Pardini Institute, Belo Horizonte, MG, Brazil

3Department of Bioequivalence, Hermes Pardini Institute, Belo Horizonte, MG, Brazil

4Multilab Indústria e Comércio de Produtos Farmacêuticos Ltda, São Jerônimo, RS, Brazil

5Jundiai Faculty of Medicine, Jundiai, SP, Brazil

6Department of Internal Medicine, Faculty of Medical Sciences, State University of Campinas, SP, Brazil

*Corresponding Author:
Dr. Ney Carter C. Borges,
24 Cesar Bierrenbach Street
Campinas, SP, Brazil
Postal Code: 13015-025
Tel/Fax: 55 19 3234-2834
E-mail : [email protected]

Received Date: September 11, 2009; Accepted Date: December 14, 2009; Published Date: December 15, 2009

Citation:Moreno RA, CostaI O, Brum Junior L, Sverdloff CE, Domingues CC, et al. (2009) Cimetidine Quantification in Human Plasma by Highperformance Liquid Chromatography Coupled to Electrospray Ionization Tandem Mass Spectrometry. Application to a Comparative Pharmacokinetics Study. J Bioanal Biomed 1: 005-013. doi: 10.4172/1948-593X.1000002

Copyright: © 2009 Moreno RA, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

A specific, fast and sensitive LC–MS/MS assay was d e- veloped for the determination of cimetidine in huma n plasma using nizatidine as the internal standard (I S). The limit of quantification was 5.0 ng/ml and the metho d was linear in the range of 5.0 to 5000 ng/ml. The cimet idine and IS retention times were 1.35±0.3 and 1.40±0.03 min, respectively. Method intra-batch precision and accu racy ranged from 2.0 to 5.4%, and 92.1 to 103.7%, respec tively. Inter-batch precision ranged from 4.2 to 6.3%, whil e In- ter-batch accuracy ranged from 97.0 to 106.6%.

The analytical method was applied to evaluate the p har- macokinetic and relative bioavailability of two dif ferent pharmaceutical formulations containing 400 mg of cimetidine containing. This study evaluated 29 volu nteers in a randomized, 2-period crossover study with 14 d ays washout period between doses. The geometric mean an d respective 90% CI of cimetidine test/reference perc ent ratios were 95.73% (87.76 - 104.43%) for C max, 100.80% (95.98 - 105.96%) for AUC 0-t and 100.90 (96.06 - 105.88) for AUC 0-inf . Based on the 90% confidence interval of the individual ratios (test formulation/reference formu lation) for C max and AUC 0-inf , it was concluded that the test formu- lation is bioequivalent to the reference one with r espect to the rate and extent of absorption of cimetidine. In addi- tion, using the Kruskal-Wallis Test no statistical differ- ences of Tmax and the Cmax were observed related to the sex of the volunteer.

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