Validation of a method for itraconazole and major metabolite hydroxyitraconazole for LC-MS/MS analysis with application in a formulation clinical study.

ABSTRACT: A high-performance liquid chromatography tandem mass spectrometry (LC-MS/MS) method was developed for the analysis of itraconazole (ITZ) and hydroxyitraconazole (ITZ-OH) as part of a human pharmacokinetic study of novel tablet formulations. We demonstrated that 100 µL of plasma sample can be used with a protein precipitation extraction by optimizing different composition of acid in organic solvent for the precipitation solvent, giving comparable recovery to more time-consuming liquid-liquid or solid phase extractions. Additionally, we have shown that by monitoring the halogen isotopic peak for ITZ as well as optimizing chromatographic conditions, we are able to avoid carryover and endogenous interferences, allowing for a lower limit of quantification for our study. We validated the method

SUBMITTER: Krug SA 

PROVIDER: S-EPMC10529130 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature