RP-HPLC法测定肿瘤患者血浆中紫杉醇浓度

Determination of Plasma Concentration of Paclitaxel in Tumor Patients by RP-HPLC

目的：建立以反相高效液相色谱法测定肿瘤患者血浆中紫杉醇浓度的方法。方法：采用有机相（乙酸乙酯）两步萃取，以反相高效色谱法测定，其中色谱柱为Tianhe Kromasil C18，流动相为乙腈-甲醇-水（40：25：40），流速为1．0mL·min^-1，检测波长为227nm，枉温为35℃。结果：血浆中紫杉醇的检测浓度在0．05～5．00mg·L^-1。范围内线性关系良好（r=0．9997）；平均加样回收率为98．75％～100．44％，日内、日间RSD均〈5％（n=5）。应用本法测定了11例患者静脉滴注紫杉醇的经一时血药浓度，其符合药动学二室模型。结论：本法简便、准确、重现性好，可用于临床血药浓度的检测及药动学研究。

OBJECTIVE： To establish a RP - HPLC method to determinate the plasma concentration of paclitaxel in tumor patients. METHODS： Paclitaxel was extracted from plasma with organic phase（ethyl- acetate） by two- step extraction on Tianhe Kromasil C18 column（250 mm× 4.6 mm, 5 μm） with a mobile phase consisted of acetonitrile - methanol - water （40 ： 25 ： 40） at a flow rate of 1 mL·min^-1 1.The detective wavelength was set at 227 nm and the column temperature was main- tained at 35 ℃. RESULTS： The linear range of paclitaxel was 0.05--5.00 mg·L^-1 （r = 0.999 7） with average recovery rate at 98.75%- 100.44% .Both intra- day RSD and inter- day RSD were less than 5% （n = 5）. The plasma concentration- time profile in 11 patients after iv infusion of paclitaxel was in line with a two- compartment model. CONCLUSION： This estab- lished method is simple, accurate, reproducible and applicable for clinical determination of blood drug concentration and pharmacokinetic studies.