高效液相色谱法常规监测中国胃肠间质瘤患者体内的伊马替尼血药浓度（英文）

发布时间：2025-01-09 02:22

　　 伊马替尼目前是胃肠间质瘤的一线治疗用药。由于伊马替尼在不同患者体内血药浓度差异较大,目前指南推荐常规监测伊马替尼的血药浓度以提高伊马替尼的疗效,降低不良反应的发生率。本研究建立了一种简单灵敏快速的高效液相色谱法,采用简单的沉淀蛋白法处理血浆样品,处理后的样品通过色谱柱Inert Sustain C18柱（250mm×4.6 mm, 5μM）进行分离,流动相为25 mM NH₄H₂PO₄ （pH=8）–乙腈（61:39, v/v）,柱温为40℃,流速为1mL/min,紫外检测波长为265nm。该方法标准曲线在50–10 000 ng/m L浓度范围内线性良好,日间与日内准确度和精密度在–5.81%–6.33%之间。绝对回收率在92.38%–97.86%之间。稳定性测试和样品再分析结果均符合指南要求。该方法成功用于150名中国胃肠间质瘤患者的常规伊马替尼血药浓度监测。

【文章页数】：12 页

【文章目录】：
1. Introduction
2. Experimental
    2.1. Chemicals and reagents
    2.2. Instrumentation and chromatographic conditions
    2.3. Sample preparation
    2.4. Preparations of stock solution,calibration standards and quality control (QC) samples
    2.5. Method validation
    2.6. Application of the method to routine plasma concentration monitoring of imatinib
3. Results
    3.1. Method development
        3.1.1. Optimization of chromatographic conditions
        3.1.2. Optimization of sample preparation
    3.2. Method validation
        3.2.1. Selectivity
        3.2.2. Linearity and sensitivity
        3.2.3. Accuracy and precision
        3.2.4. Extraction recovery
        3.2.5. Stability
        3.2.6. Application of the method to routine plasma concentration monitoring of imatinib
4. Discussion



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