超高效合相色谱法测定紫杉醇原料药的含量

目的：建立快速、准确、灵敏的测定紫杉醇原料药的方法。方法：采用沃特世ACQUITY超高效合相色谱系统（UPC2）。采用ACQUITY UPC2 BEH 2-EP柱（3.0mm×100mm,1.7mm）;以二氧化碳（A）-甲醇（B）二元梯度洗脱,0-0.2min（92：8,V：V）,0.2-2.5min（92：8-82：18,V：V）,2.5-4.0min（82：18,V：V）;流速2.2m L/min;柱温50℃;备压2200 psi;进样体积2.0m L。结果：此条件下紫杉醇分离良好,在0.6-196mg/m L浓度范围内线性关系良好,回归方程为：Y=94.74X＋404.67（r=0.9999）,平均回收率（n=9）为99.57%,相对标准偏差为0.71%。结论：UPC2法检测快速、准确、灵敏度高、重复性好,为紫杉醇原料药的质量控制提供了一种快速准确的方法。

Determination of Content of Paclitaxel using Ultra Performance Convergence Chromatography

Objective： A rapid, accurate and sensitive method is established to determine the content of paclitaxel in pharmaceutical ingredient. Method： Waters ACQUITY UPC2 was used.ACQUITY UPC2 BEH 2-EP （3.0mm× 100mm,1.7 mm） column was used with a mobile phase of CO2 and methanol, using the mobile phase of mixture of supercritical CO2 and methanol with a linear gradient elution：0-0.2 min （92：8,V：V）,0.2-2.5 min （92：8-82：18,V：V）,2.5-4.0 min （82：18, V：V）;a flow rate was 2.2mL/min;column temperature was 50℃ ;black pressure was 2200 psi and injection volume was 2.0 mL. Result：The result showed that the paclitaxel had a good linear relationship when its concentration ranged from 0.6 and 196mg/mL,The regression equation was Y=94.74X＋404.67 （r=0.9999）.The average recovery of paclitaxel was 99.57% with the a relative standard deviations （RSD） of 0.71%.Conclusion：UPC2 method is rapid, accurate and sensitive with a good repeatability, and could use for quality control of paclitaxel.