Determination of indinavir in human plasma and its use in pharmacokinetic study
DOI:
https://doi.org/10.1590/S1516-93322007000400018Keywords:
Indinavir^i1^spharmacokinetics stud, Plasma, Generic drugs^i1^spolAbstract
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.Downloads
Downloads
Published
2007-12-01
Issue
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