伊馬替尼目前是胃腸間質(zhì)瘤的一線治療用藥。由于伊馬替尼在不同患者體內(nèi)血藥濃度差異較大,目前指南推薦常規(guī)監(jiān)測(cè)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(yīng)的發(fā)生率。本研究建立了一種簡(jiǎn)單靈敏快速的高效液相色譜法,采用簡(jiǎn)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(jìn)行分離,流動(dòng)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(cè)波長(zhǎng)為265nm。該方法標(biāo)準(zhǔn)曲線在50–10 000 ng/m L濃度范圍內(nèi)線性良好,日間與日內(nèi)準(zhǔn)確度和精密度在–5.81%–6.33%之間。絕對(duì)回收率在92.38%–97.86%之間。穩(wěn)定性測(cè)試和樣品再分析結(jié)果均符合指南要求。該方法成功用于150名中國胃腸間質(zhì)瘤患者的常規(guī)伊馬替尼血藥濃度監(jiān)測(cè)。

【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(hào)：4024994