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| 雷帕霉素洗脱支架系统中雷帕霉素的含量测定 | |
| 引用本文： | 林红赛,黄永富,李剑,岳卫华. 雷帕霉素洗脱支架系统中雷帕霉素的含量测定[J]. 医疗装备, 2014, 0(8): 7-9 |
| 作者姓名： | 林红赛 黄永富 李剑 岳卫华 |
| 作者单位： | 北京市医疗器械检验所,北京101111 |
| 摘 要： | 目的：建立高效液相色谱法测定雷帕霉素洗脱支架中雷帕霉素含量测定的方法并对样品制备方法进行了验证.方法：用waters 1525高效液相色谱仪进行检测,色谱柱为C18柱（250mm ×4.6mm,5μm）,流动相为甲醇∶乙腈∶水（67∶ 15∶ 18）,流速1mL/min,紫外检测器,检测波长为280nm,外标法定量.结果：雷帕霉素的线性范围为19.2～77.6μg/mL（r=0.9993）,检出限为0.388μg/mL,平均加样回收率为98.86％.结论：该方法简便、快速、准确,可用于雷帕霉素洗脱支架系统中雷帕霉素的含量测定. |
| 关 键 词： | 雷帕霉素洗脱支架 雷帕霉素 高效液相色谱法 |
Determination of rapamycin in rapamycin - eluting stent by HPLC |
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| Affiliation: | LIN Hong - sai, HUANG Yong - fu, LI Jian, YUE Wei - hua (No. 7, Xingguang 2nd Street, Opto - Mechatronics Industial Park, Tongzhou District, Beijing, China, 101111 ) |
| Abstract: | Objective： To establish a method for determination of rapamycin in rapamyein -eluting stent by HPLC with ultraviolet detection and verify the efficiency of sample preparation. Method： HPLC analysis of rapamycin was performed by a Waters 1525 chro- matography equipped with a C18 （250mm ×4. 6mm, 5μm） column and quantified by external standard method. The mobile phase was a mixture of methanol, acetonitrile and water （67： 15： 18） and the flow rate was 1mL,/min. The detection wavelength was at 280nm. Result： The linear range of rapamycin was 19. 21μg/mL - 77.6μg/mL （ r = 0. 9993 ） . The limt detection was 0. 3881μg,/mL and the average recovery was 98.86%. Conclusion： The method is simple, rapid and accurate for the content determination of rapam- ycin in rapamycin -elating stent. |
| Keywords: | rapamycin rapamycin -eluting stent HPLC |
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