Journal of Bioanalysis & Biomedicine

Validation of an LC Method for Therapeutic Drug Monitoring of Voriconazole in Patients

Abstract

Laura Zufía, Azucena Aldaz, Nerea Ibáñez and Joaquín Giráldez

An accurate and precise LC method using diode array detection for the determination of voriconazole in human serum/plasma samples has been developed and validated for use in pharmacokinetic studies.

A harmonized validation strategy based on the accuracy profiles was used as a suitable tool to guaranty the quality of the results obtained by the use of the analytical validated methodology in a routine setting and to ensure the risk of obtaining the future measurements outside the previously fixed acceptance limits.

As pointed recently the FDA, a weighted 1/x2 linear regression model ranging from 0.25 to 10.35 mg/L was selected as the simplest calibration model that maximized the accuracy all over the range. Relative bias was < 7%, assay imprecision was always < 4% and mean extraction recovery from plasma was > 90%. So, accuracy did not exceed the acceptance limits settled at±15% according to the FDA or Washington conference regulatory requirements for bioanalytical methods.

The validated analytical procedure compliants with strongest regulatory standards and their results are rapid and good enough to enable the laboratory to routinely provide useful and accurate pharmacokinetic data in time to adjust patient regimens.