【摘要】：目的:建立超高效液相色譜-質(zhì)譜聯(lián)用(UHPLC-MS/MS)測(cè)定尿液中莎巴比星及其代謝物M3濃度的方法,用于小細(xì)胞肺癌Ⅰ期臨床尿液中藥動(dòng)學(xué)研究。方法:多柔比星作為內(nèi)標(biāo),用氯仿進(jìn)行液液萃取處理,選用ACQUITY UPLC BEH Shield RP18色譜柱(100 mm×2.1 mm,1.7μm)分離,流動(dòng)相為0.1%甲酸水-乙腈(90∶10,V/V),流速0.3 m L·min~(-1)。采用ESI正離子方式進(jìn)行檢測(cè),用于定量分析的檢測(cè)離子為莎巴比星m/z 644.2→130.2、M3 m/z 646.2→130.1和多柔比星m/z 544.3→397.1。結(jié)果:莎巴比星和M3在2~200 ng·m L~(-1)范圍內(nèi)呈良好的線性擬合關(guān)系(r0.99)。在目標(biāo)化合物出峰時(shí)間處,未觀察到基質(zhì)的內(nèi)源性成分干擾,殘留率可接受,并對(duì)方法的選擇性、提取回收率、基質(zhì)效應(yīng)、精密度與準(zhǔn)確度以及部分穩(wěn)定性等進(jìn)行了驗(yàn)證,均符合FDA和CFDA指導(dǎo)原則的要求,且該方法在臨床預(yù)實(shí)驗(yàn)入組患者尿液藥物分析中進(jìn)行驗(yàn)證。結(jié)論:本方法可靈敏、準(zhǔn)確、快速地測(cè)定尿液中莎巴比星和代謝物M3的濃度,能夠滿足臨床藥動(dòng)學(xué)研究的需求。
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圖片說(shuō)明：莎巴比星、M3及內(nèi)標(biāo)的質(zhì)譜碎裂圖
[Abstract]:Objective: to establish an ultra-high performance liquid chromatography-mass spectrometry (UHPLC-MS/MS) method for the determination of Sababisin and its metabolite M3 in urine for the kinetic study of traditional Chinese medicine in stage I clinical urine of small cell lung cancer. Methods: doxorubicin was used as internal standard and chloroform was used for liquid-liquid extraction. ACQUITY UPLC BEH Shield RP18 column (100 mm 脳 2.1 mm, 1.7 渭 m) was used to separate doxorubicin. The mobile phase was 0.1% formate water-acetonitrile (90 脳 10, V 鈮，

本文編號(hào)：2512142