伊馬替尼目前是胃腸間質瘤的一線治療用藥。由于伊馬替尼在不同患者體內血藥濃度差異較大,目前指南推薦常規(guī)監(jiān)測伊馬替尼的血藥濃度以提高伊馬替尼的療效,降低不良反應的發(fā)生率。本研究建立了一種簡單靈敏快速的高效液相色譜法,采用簡單的沉淀蛋白法處理血漿樣品,處理后的樣品通過色譜柱Inert Sustain C18柱（250mm×4.6 mm, 5μM）進行分離,流動相為25 mM NH₄H₂PO₄ （pH=8）–乙腈（61:39, v/v）,柱溫為40℃,流速為1mL/min,紫外檢測波長為265nm。該方法標準曲線在50–10 000 ng/m L濃度范圍內線性良好,日間與日內準確度和精密度在–5.81%–6.33%之間。絕對回收率在92.38%–97.86%之間。穩(wěn)定性測試和樣品再分析結果均符合指南要求。該方法成功用于150名中國胃腸間質瘤患者的常規(guī)伊馬替尼血藥濃度監(jiān)測。

【文章頁數(shù)】：12 頁

【文章目錄】：
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



本文編號：4024994