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Related Experiment Videos

Fluconazole bioequivalence study: quantification by tandem mass spectrometry.

L A Moraes1, F E Lerner, M E Moraes

  • 1Department of Pharmacology, Institute of Biomedical Sciences, São Paulo University, Brazil.

Therapeutic Drug Monitoring
|April 27, 1999
PubMed
Summary

This study developed a new method for quantifying fluconazole and found that Fluconal is bioequivalent to Zoltec. The analysis confirmed consistent absorption and rate of absorption between the two fluconazole formulations.

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Area of Science:

  • Pharmacokinetics
  • Analytical Chemistry
  • Bioequivalence Studies

Background:

  • Fluconazole is an antifungal medication requiring accurate quantification in plasma.
  • Comparing bioavailability of different drug formulations is crucial for therapeutic equivalence.

Purpose of the Study:

  • To develop and validate a liquid chromatography-electrospray tandem mass spectrometry method for fluconazole quantification.
  • To compare the bioavailability of two fluconazole capsule formulations (Fluconal and Zoltec).

Main Methods:

  • An open, randomized, two-period crossover study in 24 healthy volunteers.
  • Plasma fluconazole concentrations analyzed using LC-MS/MS with multiple reaction monitoring.
  • Key pharmacokinetic parameters (AUC, Cmax, Tmax, half-life) were calculated.

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Main Results:

  • The developed LC-MS/MS method demonstrated good precision and accuracy.
  • Fluconal and Zoltec were found to be bioequivalent for AUC (Area Under the Curve) and Cmax (Maximum Concentration).
  • High variability (CV 27.5%) was observed in the rate of fluconazole absorption.

Conclusions:

  • The validated LC-MS/MS method is suitable for pharmacokinetic analysis of fluconazole.
  • Fluconal is bioequivalent to Zoltec regarding drug absorption and rate of absorption.
  • The high variability in absorption rate warrants consideration in clinical practice.