RPHPLC法测定复合洗脱支架中西罗莫司和普罗布考的含量.pdf

RP-HPLC 法测定复合洗脱支架中西罗莫司和普罗布考的含量 杜玲玲，罗启剑，刘宗军(1.上海交通大学医学院附属仁济医院，上海市 200001； 2.复旦大学附属华山医院，上海市 200040；3.上海中医药大学附属普陀医院， 上海市 200062) 中图分类号 R927.2 文献标识码 A 文章编号 1001-0408(2008)07-0536-02 摘 要 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 -1 方法。方法:色谱柱为Kromasil C18，流动相为乙腈-水(梯度洗脱)，流速为1.0 mL ·min ， 检测波长为277 nm，柱温为55 ℃，进样量为20 μ L。结果:西罗莫司和普罗布考检测浓度 -1 的线性范围均为1.0~20.0 μ g ·mL (r=0.999 9)；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。 关键词 西罗莫司；普罗布考；复合洗脱支架；反相高效液相色谱法；含量 Determination of Sirolimus and Probucol in Mixed-eluting Stents by RP-HPLC DU Ling_ling(Renji Hospital of Medical College， Shanghai Jiaotong University， Shanghai 200001， China) LUO Qi_jian(Huashan Hospital Affiliated to Fudan University， Shanghai 200040， China) LIU Zong_jun(Putuo Hospital Affiliated to Shanghai TCM University，Shanghai 200062， China) ABSTRACT 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 1.0 mL ·min . The detection wavelength was 277 nm； the column temperature was 55 ℃ and the sample size was 20 μ L. RESULTS: The calibration curves of sirolimus and probuol were linear in the range of 1.0~20.0 μ g ·mL-1 (r=0.999 9). 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 sim-ple， accurate and can be used to determine the contents of of sirolimus and probucol in the mixed-eluting stents. KEY WORDS Sirolimus； Probucol； Mixed-eluting stent； RP-HPLC； Content [1] 西罗莫司洗脱支架(Cyphe