African Journal of
Pharmacy and Pharmacology

  • Abbreviation: Afr. J. Pharm. Pharmacol.
  • Language: English
  • ISSN: 1996-0816
  • DOI: 10.5897/AJPP
  • Start Year: 2007
  • Published Articles: 2288

Full Length Research Paper

Development of a simple and rapid method for the determination of cimetidine in human plasma by high performance liquid chromatography-mass spectrometry (HPLC-MS/MS): Application to a bioequivalence study

Carlos Eduardo Miranda de Sousa
  • Carlos Eduardo Miranda de Sousa
  • Departamento de Ciências Farmacêuticas, Núcleo de Desenvolvimento Farmacêutico e Cosmético, Universidade Federal de Pernambuco - UFPE, Centro de Ciências da Saúde - CCS,? NUDFAC, Brazil.
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Maria Alice Maciel Tabosa*
  • Maria Alice Maciel Tabosa*
  • Departamento de Ciências Farmacêuticas, Núcleo de Desenvolvimento Farmacêutico e Cosmético, Universidade Federal de Pernambuco - UFPE, Centro de Ciências da Saúde - CCS,? NUDFAC, Brazil.
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Ellison Neves de Lima
  • Ellison Neves de Lima
  • Departamento de Ciências Farmacêuticas, Núcleo de Desenvolvimento Farmacêutico e Cosmético, Universidade Federal de Pernambuco - UFPE, Centro de Ciências da Saúde - CCS,? NUDFAC, Brazil.
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José Homero de Souza Filho
  • José Homero de Souza Filho
  • Departamento de Ciências Farmacêuticas, Núcleo de Desenvolvimento Farmacêutico e Cosmético, Universidade Federal de Pernambuco - UFPE, Centro de Ciências da Saúde - CCS,? NUDFAC, Brazil.
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Danilo César Galindo Bedor
  • Danilo César Galindo Bedor
  • Departamento de Ciências Farmacêuticas, Núcleo de Desenvolvimento Farmacêutico e Cosmético, Universidade Federal de Pernambuco - UFPE, Centro de Ciências da Saúde - CCS,? NUDFAC, Brazil.
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Leila Bastos Leal
  • Leila Bastos Leal
  • Departamento de Ciências Farmacêuticas, Núcleo de Desenvolvimento Farmacêutico e Cosmético, Universidade Federal de Pernambuco - UFPE, Centro de Ciências da Saúde - CCS,? NUDFAC, Brazil.
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Davi Pereira de Santana
  • Davi Pereira de Santana
  • Departamento de Ciências Farmacêuticas, Núcleo de Desenvolvimento Farmacêutico e Cosmético, Universidade Federal de Pernambuco - UFPE, Centro de Ciências da Saúde - CCS,? NUDFAC, Brazil.
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  •  Received: 17 August 2014
  •  Accepted: 24 November 2014
  •  Published: 15 December 2014

Abstract

Bioanalytical methods for bioequivalence studies require high sensibility and rapidity due to the large number of samples and the low plasma concentration of drugs. The present study aimed to develop and validate a high-performance liquid chromatography coupled to sequential mass spectrometry (HPLC-MS/MS) method to quantify cimetidine (CMT) in human plasma and to apply it in a bioequivalence study. CMT and the internal standard, ranitidine, were extracted from plasma by liquid-liquid extraction. After extraction, the samples were analysed by HPLC-MS/MS. The chromatographic separation was performed with a C18 column, and the mobile phase was composed of acetonitrile and ammonium acetate buffer 10 mM to which 5% isopropyl alcohol and 0.1% formic acid were added. The recovery of CMT was 67.14% in a linear range from 25 to 6000 ng ml-1. The intraday and interday precision and accuracy were within specified limits. In conclusion, the developed method was precise and accurate and was successfully applied to the bioequivalence study of two formulations of CMT.

 

Key words: Cimetidine, bioequivalence, HPLC-MS/MS, validation.

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This article is published under the terms of the Creative Commons Attribution License 4.0

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