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建立一种 LC-MS/MS 法,用于同时定量测定人血浆中的阿比特龙、恩杂鲁胺和达罗他胺。

Validation of an LC-MS/MS method for simultaneous quantification of abiraterone, enzalutamide and darolutamide in human plasma.

机构信息

Department of Medical Oncology, Erasmus MC Cancer Institute, University Medical Center Rotterdam, The Netherlands.

Department of Medical Oncology, Erasmus MC Cancer Institute, University Medical Center Rotterdam, The Netherlands.

出版信息

J Chromatogr B Analyt Technol Biomed Life Sci. 2023 Jun 1;1225:123752. doi: 10.1016/j.jchromb.2023.123752. Epub 2023 May 26.

DOI:10.1016/j.jchromb.2023.123752
PMID:37269569
Abstract

Currently, several oral androgen receptor signalling inhibitors are available for the treatment of advanced prostate cancer. Quantification of plasma concentrations of these drugs is highly relevant for various purposes, such as Therapeutic Drug Monitoring (TDM) in oncology. Here, we report a liquid chromatography/tandem mass spectrometric (LC-MS/MS) method for the simultaneous quantification of abiraterone, enzalutamide, and darolutamide. The validation was performed according to the requirements of the U.S. Food and Drug Administration and European Medicine Agency. We also demonstrate the clinical applicability of the quantification of enzalutamide and darolutamide in patients with metastatic castration-resistant prostate cancer.

摘要

目前,有几种口服雄激素受体信号抑制剂可用于治疗晚期前列腺癌。这些药物的血浆浓度定量对于各种目的都非常重要,例如肿瘤学中的治疗药物监测 (TDM)。在这里,我们报告了一种液相色谱/串联质谱 (LC-MS/MS) 方法,用于同时定量检测阿比特龙、恩扎鲁胺和达罗他胺。验证是根据美国食品和药物管理局和欧洲药品管理局的要求进行的。我们还展示了定量检测转移性去势抵抗性前列腺癌患者恩扎鲁胺和达罗他胺的临床适用性。

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