高效液相色谱法测定药物涂层支架中zotarolimus的含量  

Determination of the Content of Zotarolimus on the Drug Eluting Stents by HPLC

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作  者:李沅[1] 姜熙[1] 樊铂[1] 崔红[1] 

机构地区:[1]天津市医疗器械质量监督检验中心,天津300191

出  处:《中国医疗器械杂志》2011年第2期134-136,共3页Chinese Journal of Medical Instrumentation

摘  要:目的建立药物涂层支架中zotarolimus的含量测定方法。方法高效液相色谱法,使用Zorbax Eclipse XDB-C8(4.6×75mm3.5mm)色谱柱;流动相MPA(醋酸盐缓冲液:乙腈=51:49)、MPB(醋酸盐缓冲液:乙腈=5:95);检测波长278nm。结果在质量浓度5mg/ml~75mg/ml范围内与峰面积呈良好的线性关系(r=0.99986),平均回收率为101.58%,RSD=0.68%(n=6)。结论本方法简便、准确、重现性好,可用于药物涂层支架中zotarolimus的含量测定。Object To establish a method for the content determination of zotarolimus on the durg eluting stents. Methods HPLC analysis was carried out with Zorbax Eclipse C8 colum(4.6 ×75 mm 3.5 um)and MPA acetate buffer solution: acetonitrile (51:49), MPB acetate buffer solution: acetonitrile(5:95)as the mobile phase. The detection wavelength was 278 nm. Result There was a good linear relationship between the concentration of zotarolimus and the areas in the range of 5 ug/ml-75 ug/ml (r=0.99986). The average recovery was 101.58% with RSD 0.68%(n=6). Conclusion The method is simple, accurate and reproducible. It can be used as the quality test for zotarolimus on the durg eluting stents,

关 键 词:高效液相色谱法 药物涂层支架 ZOTAROLIMUS 含量测定 

分 类 号:TH781[机械工程—仪器科学与技术]

 

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