Enko Dietmar, Zelzer Sieglinde, Herrmann Markus, Krause Robert, Meinitzer Andreas
Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Graz, Austria.
Institute of Clinical Chemistry and Laboratory Medicine, General Hospital Hochsteiermark, Leoben, Austria.
J Lab Physicians. 2021 Jun;13(2):123-128. doi: 10.1055/s-0041-1730755. Epub 2021 Jun 15.
Therapeutic drug monitoring (TDM) of isavuconazole, which is a novel broad-spectrum antimycoticum against invasive fungal infections, ensures an effective exposure of the drug and minimizes the risk of toxicity. This study is aimed at evaluating the analytical performance of a dual-column liquid chromatography-tandem mass-spectrometry (LC-MS/MS) method for isavuconazole quantification. The method was performed on a Voyager TSQ Quantum triple quadrupole instrument equipped with an Ultimate 3000 chromatography system (Thermo Fisher Scientific, San Jose, California, United States). Analytical and preanalytical requirements of the isavuconazole LC-MS/MS method were evaluated. Sample stability measurements were performed at room temperature (RT) and in serum tubes with separator gel. The isavuconazole LC-MS/MS method was linear over the concentration range of 0.2 to 12.8 mg/L. The coefficient of determination ( ) always exceeded 0.999. Within- and between-run precision ranged between 1.4 to 2.9% and 1.5 to 3.0%, the recovery between 93.9 and 102.7%. At RT, serum samples were stable for 3 days. Isavuconazole serum concentrations were significantly lower after incubation (18 hours) in serum tubes with separator gel at RT. The dual-column isavuconazole LC-MS/MS is a reliable tool for the TDM of isavuconazole. Serum samples are stable for at least 3 days and should be collected in tubes without separator gel.
艾沙康唑是一种新型的抗侵袭性真菌感染的广谱抗真菌药物，对其进行治疗药物监测（TDM）可确保药物有效暴露，并将毒性风险降至最低。本研究旨在评估一种用于定量艾沙康唑的双柱液相色谱 - 串联质谱（LC-MS/MS）方法的分析性能。
该方法在配备了Ultimate 3000色谱系统的Voyager TSQ Quantum三重四极杆仪器上进行（美国加利福尼亚州圣何塞的赛默飞世尔科技公司）。对艾沙康唑LC-MS/MS方法的分析和分析前要求进行了评估。在室温（RT）和含有分离胶的血清管中进行了样品稳定性测量。
艾沙康唑LC-MS/MS方法在0.2至12.8 mg/L的浓度范围内呈线性。决定系数（ ）始终超过0.999。批内和批间精密度范围分别为1.4%至2.9%和1.5%至3.0%，回收率在93.9%至102.7%之间。在室温下，血清样品稳定3天。在室温下于含有分离胶的血清管中孵育（18小时）后，艾沙康唑血清浓度显著降低。
双柱艾沙康唑LC-MS/MS是艾沙康唑TDM的可靠工具。血清样品至少稳定3天，应收集在不含分离胶的试管中。
