Mueller Silke C, Karasch Ilona, Lakner Johannes, Wacke Rainer
Center for Pharmacology and Toxicology, Institute of Clinical Pharmacology, University Medicine Rostock.
Center for Internal Medicine, Clinic for Hematology and Oncology, University Medicine Rostock, Rostock, Germany.
Ther Drug Monit. 2018 Aug;40(4):503-506. doi: 10.1097/FTD.0000000000000524.
Isavuconazole is a triazole antifungal agent for treatment of invasive aspergillosis and mucormycosis. At present, it is unclear whether a therapeutic drug monitoring (TDM) of isavuconazole would be necessary. The aim of the investigation was to validate a high-performance liquid chromatography (HPLC) assay for routine applications.
An HPLC assay for routine determination of isavuconazole in plasma has been adapted and validated. The assay used the reagents and HPLC column provided by the ChromSystems HPLC Kit for TDM of itraconazole, posaconazole, and voriconazole. Isocratic flow rate was set at 1.0 mL/min. Detection was performed using a fluorescence detector with excitation wavelength set at 261 nm and emission wavelength set at 366 nm.
The assay was linear between 0.15 and 10 mg/L with intraday and interday imprecision and accuracy <10% (<20% at lower limit of quantification). The method was applied to routine TDM of 7 patients after hematopoietic stem cell transplantation (n = 31 samples). In these patients, trough levels ranged from 0.45 to 3.06 mg/L (median 1.44 mg/L).
A robust and simple HPLC assay of isavuconazole in plasma for routine TDM applications is presented.
艾沙康唑是一种用于治疗侵袭性曲霉病和毛霉病的三唑类抗真菌药物。目前，尚不清楚是否有必要对艾沙康唑进行治疗药物监测（TDM）。本研究的目的是验证一种适用于常规应用的高效液相色谱（HPLC）测定法。
已对一种用于血浆中艾沙康唑常规测定的HPLC测定法进行了调整和验证。该测定法使用了ChromSystems HPLC试剂盒提供的试剂和HPLC柱，用于伊曲康唑、泊沙康唑和伏立康唑的TDM。等度流速设定为1.0 mL/min。使用荧光检测器进行检测，激发波长设定为261 nm，发射波长设定为366 nm。
该测定法在0.15至10 mg/L之间呈线性，日内和日间不精密度及准确度<10%（定量下限处<20%）。该方法应用于7例造血干细胞移植患者的常规TDM（n = 31份样本）。在这些患者中，谷浓度范围为0.45至3.06 mg/L（中位数1.44 mg/L）。
本文介绍了一种用于血浆中艾沙康唑常规TDM应用的稳健且简单的HPLC测定法。
