RP-HPLC法测定硼替佐米原料药中主药的含量

Determination of Bortezomib in Its Crude Drug by RP-HPLC

目的:建立以反相高效液相色谱法测定硼替佐米原料药中主药含量的方法。方法:色谱柱为Phenomenex-C18,流动相为甲醇-磷酸盐缓冲液(pH2.0)=60∶40,检测波长为254nm,流速为1.0mL.min-1。结果:硼替佐米检测浓度的线性范围为50.72～152.16μg·mL-1(r=0.9999);平均回收率为99.62%,RSD=0.39%(n=6)。结论:本方法灵敏度高、专属性强、操作简便,可用于该原料药的含量测定。

OBJECTIVE. To establish an RP - HPLC method for determination of the content of bortezomib in its crude drug. METHODS： Bortezomib was separated on Phenomenex- C18 chromatographic column with mobile phase consisted of methanol - phosphate buffer （pH 2.0） （60 ： 40） at a flow rate of 1.0 mL · min -1.The detection wavelength was set at 254 nm. RESULTS： The linear range of bortezomib was 50.72--152.16μg （r = 0.999 9） with an average recovery rate of 99.62% （RSD = 0,39%, n = 6） . CONCLUSIONS： The method is sensitive, specific and simple in operation, and it is applicable for the determination of bortezomib in its crude drug.