Development, optimization and validation of an analytical method for the determination of voriconazole in plasma by high-performance liquid chromatography-ultraviolet detection: Application for comprehensive study.

ABSTRACT

OBJECTIVES: Voriconazole is a widely used antifungal agent in clinical settings. However, its use has been associated with neurological side effects in some patients. For this reason, it is crucial to monitor its plasma levels to ensure that they are within the therapeutic range. Thus, in this study, we aimed to develop a simple, fast, and efficient method for the determination of voriconazole in plasma using reversed-phase HPLC-UV. We also aimed to validate the method for its application to routine analysis of immunocompromised patients. MATERIAL AND METHODS: Plasma samples from immunocompromised patients were subjected to deproteinization with acetonitrile followed by centrifugation. Chromatographic separation was carried out on a C18 column with UV detection at 254nm in isocratic mode. The concentrations were calculated by comparing peak areas to those of the internal standard, ketoconazole. The method was validated using the accuracy profile, which uses a calibration curve established for the therapeutic range of 1 to 5.5µg/mL. RESULTS: The developed method was proved to be rapid by giving a short analysis time for voriconazole at around 5.5min. Additionally, no interference with the biological matrix was detected. The obtained recoveries were higher than 90%. The accuracy profile showed that the method was accurate and precise for the determination of voriconazole in plasma. CONCLUSION: The developed method was proved to be simple, efficient, that requires minimal sample preparation. Thus, it can be routinely applied for the therapeutic monitoring of voriconazole.