本研究的目的是建立一种简单、灵敏的高效液相色谱方法，用于监测维奈托克（VEN）的治疗药物并优化治疗方案。分析需要提取 50μl 血浆样品，并使用乙腈萃取沉淀蛋白质。色谱方法采用乙腈：0.5% KH2PO4 (pH 3.5) (60/40, v/v) 为流动相，Diamond C18 (4.6 mm × 250 mm, 5 μm) 柱，流速 1.0 ml/min 。定量方法根据美国食品和药物管理局 (FDA) 出版的《生物分析方法验证：工业指南》中描述的标准进行验证。校准曲线在 75-4800ng/ 范围内呈线性 (R2 = 0.9998)。 ml，定量限为 25 ng/ml。日内和日间验证系数、特异性、回收率和稳定性均符合 FDA 指导标准。该方法成功应用于分析30例急性髓系白血病患者的VEN浓度。急性髓系白血病患者的峰浓度（Cmax）为1881.19 ± 756.61 ng/ml，谷浓度（Cmin）为1212.69 ± 767.92 ng/ml。我们的研究建立了一种简单、精密、灵敏的高效液相色谱方法用于监测 VEN 并确认其适用于血液癌症中 VEN 的治疗药物监测。版权所有 © 2024 Wolters Kluwer Health, Inc. 保留所有权利。

The aim of this study was to establish a simple and sensitive high-performance liquid chromatography method for therapeutic drug monitoring of venetoclax (VEN) and optimize regimens.The analysis required the extraction of a 50 μl plasma sample and the precipitation of proteins using acetonitrile extraction. The chromatographic method employed a mobile phase of acetonitrile: 0.5% KH2PO4 (pH 3.5) (60/40, v/v) on a Diamond C18 (4.6 mm × 250 mm, 5 μm) column at a flow rate of 1.0 ml/min. The quantitative method was validated based on standards described in 'Bioanalytical Method Validation: Guidance for Industry' published by the US Food and Drug Administration (FDA).The calibration curve was linear (R2 = 0.9998) over the range of 75-4800 ng/ml, with limits of quantification of 25 ng/ml. The coefficients of intraday and interday validation, specificity, recovery, and stability all met the criteria of FDA guidance. The method was successfully applied to analyze VEN concentrations in 30 cases of acute myeloid leukemia patients. The peak concentration (Cmax) was 1881.19 ± 756.61 ng/ml, while the trough concentration (Cmin) was 1212.69 ± 767.92 ng/ml in acute myeloid leukemia patients.Our study establishes a simple, precise, and sensitive high-performance liquid chromatography method for monitoring VEN and confirms its applicability for therapeutic drug monitoring of VEN in hematological cancers.Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.