Ultra-performance liquid chromatography electrospray ionization-tandem mass spectrometry method for the simultaneous determination of itraconazole and hydroxy itraconazole in human plasma

摘要

A highly sensitive,selective,and precise ultra-performance liquid chromatography tandem mass spectrometry method was developed and validated for simultaneous quantification of itraconazole and hydroxy itraconazole in human plasma by a single liquid-liquid extraction step.The precursor to product ion transitions of m/z 705.3/392.3.m/z 721.2/408.3 and m/z 708.2/435.4 were used to detect and quantify itraconazole,hydroxy itraconazole and itraconazole-d3 respectively.The lower limit of quantitation was found to be 0.500 ng/mL for itraconazole and 1.00 ng/mL for hydroxy itraconazole.The mean recoveries for itraconazole and hydroxy itraconazole were found to be 100.045% and 100.021%,respectively.This developed method with a chromatographic run time of 2.0 min was successfully applied to a bioequivalence study of 100 mg itraconazole capsule.