帕唑帕尼
串联质谱法
选择性反应监测
医学
治疗药物监测
不利影响
色谱法
药理学
药品
质谱法
化学
内科学
癌症
舒尼替尼
作者
Ken Shiraiwa,Yosuke Suzuki,Kazuhiro Tanaka,Masanori Kawano,Tatsuya Iwasaki,Asako Matsumoto,Ryota Tanaka,Ryosuke Tatsuta,Hiroshi Tsumura,Hidenori Itoh
出处
期刊:Therapeutic Drug Monitoring
[Ovid Technologies (Wolters Kluwer)]
日期:2021-06-01
卷期号:43 (3): 416-421
被引量:1
标识
DOI:10.1097/ftd.0000000000000821
摘要
Pazopanib is widely used to treat renal cell carcinomas and soft tissue tumors in Japan. Pazopanib has significant therapeutic efficacy but it is associated with frequent severe adverse effects. Therapeutic drug monitoring (TDM) may help to prevent adverse effects. A more convenient and rapid pazopanib assay is desirable for the application of TDM in clinical settings. In this study, the authors developed a high-throughput method for quantifying pazopanib in human plasma using ultra-high-performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS).After a simple solid-phase extraction step using a 96-well plate, pazopanib was analyzed by UHPLC-MS/MS in the positive electrospray ionization mode.The novel method fulfilled the requirements of the US Food and Drug Administration and the European Medicines Agency guidelines for assay validation, and the lower limit of quantification was 0.5 mcg/mL. The calibration curves were linear over the concentration range of 0.5-100 mcg/mL. The average recovery rate was 102.0% ± 3.9% (mean ± SD). The precision was below 5.0%, and the accuracy was within 12.0% for all quality control levels. Matrix effect varied between 90.9% and 97.1%. This assay was successfully applied to TDM of pazopanib trough concentrations in 3 patients treated with the drug for soft tissue tumors.The authors succeeded in developing a novel high-throughput UHPLC-MS/MS method for quantifying pazopanib in human plasma. This method can be applied to TDM of patients receiving pazopanib in clinical settings.
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