Determination of indinavir in human plasma and its use in pharmacokinetic study

Authors

  • Talita Mota Gonçalves Universidade Federal de Pernambuco; Departamento de Ciências Farmacêuticas; Núcleo de Desenvolvimento Farmacêutico e Cosmético
  • Breno Xavier Fernandes Pires Universidade Federal de Pernambuco; Departamento de Ciências Farmacêuticas; Núcleo de Desenvolvimento Farmacêutico e Cosmético
  • Danilo César Galindo Bedor Universidade Federal de Pernambuco; Departamento de Ciências Farmacêuticas; Núcleo de Desenvolvimento Farmacêutico e Cosmético
  • Vanessa Cristina de Souza Universidade Federal de Pernambuco; Departamento de Ciências Farmacêuticas; Núcleo de Desenvolvimento Farmacêutico e Cosmético
  • Luis Renato Pires de Abreu Universidade Federal de Pernambuco; Departamento de Ciências Farmacêuticas; Núcleo de Desenvolvimento Farmacêutico e Cosmético
  • Davi Pereira de Santana Universidade Federal de Pernambuco; Departamento de Ciências Farmacêuticas; Núcleo de Desenvolvimento Farmacêutico e Cosmético

DOI:

https://doi.org/10.1590/S1516-93322007000400018

Keywords:

Indinavir^i1^spharmacokinetics stud, Plasma, Generic drugs^i1^spol

Abstract

We report the development and validation of a new sensitive, accurate and precise HPLC method with ultraviolet detection for the determination of indinavir sulfate (IND) in human plasma and its application to a bioequivalence study of a new generic formulation. The extraction of IND from plasma samples was achieved by using liquid-liquid extraction with a mean recovery of 73.9%. The lower limit of quantification was 0.05 µg/mL. Bioequivalence between the products was determined by calculating 90% confidence intervals (CI) for the ratio of Cmax, AUC0-t and AUC0-inf values for the test and reference products, within the 0.80-1.25 interval proposed by ANVISA and FDA. Therefore the medications are bioequivalent and inter-exchangeable.

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Published

2007-12-01

Issue

Vol. 43 No. 4 (2007)

Section

Original Papers

How to Cite

Determination of indinavir in human plasma and its use in pharmacokinetic study. (2007). Revista Brasileira De Ciências Farmacêuticas, 43(4), 639-647. https://doi.org/10.1590/S1516-93322007000400018