高效液相色谱法测定非小细胞肺癌患者血浆中紫杉醇浓度

Determination of paclitaxel in human plasma by HPLC

目的:建立测定非小细胞肺癌(NSCLC)患者血浆中紫杉醇的高效液相色谱方法,用于考察紫杉醇联合顺铂治疗NSCLC的疗效,不良反应与血药浓度之间的关系。方法:血浆样品经碳酸氢钠碱化后用乙醚提取处理。色谱柱为Agilent C18柱(250mm×4.6mm,5μm),流动相为50mmol·L-1醋酸铵水溶液-乙腈(55∶45),流速为1.0mL·min-1,检测波长为230nm。结果:紫杉醇线性范围为10～640μg·L-1,方法回收率在100.6%～112.6%之间,日内和日间的精密度均小于8.6%。结论:该方法样品处理过程简便,重复性好,符合生物样品的测定要求,可适用于临床血药浓度监测和药动学研究。

OBJECTIVE To develop an HPLC method for determination of paclitaxel in human plasma and to study paclitaxel combined with cisplatin in the treatment of advanced non-small cell lung cancer （NSCLC）. METHODS After alkalization with NaHCO3, plasma were extracted by diethyl ether. Chromatography was performed on Agilent C18 column （250 mm×4. 6 mm, 5μm）. The mobile phase consisted of 50 mmol·L^-1 ammonium acetateacetonnitrile （55：45） at the flow rate of 1.0 mL·L^-1 and UV detection wavelength was 230 nm. RESULTS Calibration curve was linear over the concentration range of 10-640μg·L^-1. The method recovery of paclitaxel from plasma was in the range of 100. 6%-112. 6%. The intra-day and inter-day variability values were less than 8.6%. CONCLUSION The established HPLC method is simple, accurate, sensitive and applicable for therapeutic drug monitoring and the pharmacokinetic study.