RP-HPLC法测定复合洗脱支架中西罗莫司和普罗布考的含量

目的:建立以反相高效液相色谱法测定复合洗脱支架中西罗莫司和普罗布考含量的方法。方法:色谱柱为Kromasil C18,流动相为乙腈-水(梯度洗脱),流速为1.0mL·min-1,检测波长为277nm,柱温为55℃,进样量为20μL。结果:西罗莫司和普罗布考检测浓度的线性范围均为1.0~20.0μg.mL-1(r=0.9999);平均加样回收率分别为99.47%、98.35%,日内、日间RSD均小于5%。结论:本方法简便、准确,可用于西罗莫司-普罗布考复合洗脱支架的含量测定。

Determination of Sirolimus and Probucol in Mixed-eluting Stents by RP-HPLC

OBJECTIVE ： To develop a RP HPLC method for a simultaneously determination of the contents of sirolimus and probucol in the mixed-eluting stents. METHODS： Kromasil C18 column was used as an analytical column; the mobile phase consisted of acetonitrile and water which eluted by a gradient procedure at a flow rate of 1.0 mL·min^-1. The detection wavelength was 277 nm; the column temperature was 55℃ and the sample size was 20μL. RESULTS： The calibration curves of sirolimus and probuol were linear in the range of 1.0-20.0μg·mL^-1（r = 0.9999）. The average recoveries were 99.47% and 98.35%, respectively, with intra day RSD and inter-day RSD all less than 5% . CONCLUSION： The method is simple, accurate and can be used to determine the contents of of sirolimus and probucol in the mixed-eluting stents.