反相高效液相色谱法检测人血浆伊马替尼的浓度

Determination of imatinib in human plasma by RP- HPLC

目的建立人血浆伊马替尼检测的高效液相色谱方法。方法色谱柱为ZORBAX XDB-C18(150 mm×4.6 mm,5μm);以乙腈-0.1%三氟乙酸-水(20∶40∶40)为流动相,流速为1.0 mL·min-1;检测波长为282 nm,柱温为35℃,以加替沙星为内标,血浆经高氯酸沉淀后检测。结果血浆伊马替尼浓度在0.10～10.00 mg·L-1范围内线性关系良好(r=0.999 7);低、中、高3个浓度(0.25,2.50,7.50 mg·L-1)的日内RSD分别为4.02%,3.64%和2.54%,日间RSD分别为5.08%,3.25%和2.48%;相对回收率分别为(99.76±5.07)%,(101.08±328)%和(100.15±2.48)%。结论该方法简便、快速、准确,适用于伊马替尼临床治疗药物监测及其药代动力学研究。

Objective To develop a HPLC method for the determination of imatinib in human plasma. Methods The analytical column was packed with ZORBAX XDB -C18. A mixture of acetonitrile-0. 1% trif- luoroacetic acid-water（20：40：40）was used as the mobile phase with the flow rate at 1.0 mL·min^-1 The detection wavelength was 282 nm. The column temperature was 35 ℃. Gatifloxacin was used as internal standard, plasma was precipited by perchloric acid and imatinib was detected. Results Excellent liner relationship was obtained from the range of 0. 10 mg·L^-1 to 10.00mg·L^-1 （ r = 0. 999 7 ）. The intra - day RSD were 4.02%,3.64%,2.54% and inter - day RSD were 5.08%, 3.25% , 2.48% at three concentrations （0. 25,2. 50,7.50mg·L^-1）, the relative recovery rates were （99.76 ± 5.07 ）%, （ 101.08± 3.28 ）% and （ 100. 15 ± 2. 48 ） %, respectively. Conclusion The method is simple, rapid, accurate and could be suitable for imatinib clinical therapeutic drug monitoring and its pharmacokinetics study.