反相HPLC法测定西洛他唑片的含量及有关物质  

RP-HPLC Determination of Cilostazol Tablets and Its Related Substances

作　　者：王建[1] 李毓[1] 陈红[1] 杜亚俊 郑珊[1] 张宝顺[1] 袁吕江[1] 

机构地区：[1]西南大学药学院,重庆400716

出　　处：《西南师范大学学报（自然科学版）》2015年第12期118-123,共6页Journal of Southwest China Normal University(Natural Science Edition)

基　　金：国家自然科学基金青年项目(201402160);重庆市应用开发项目(CSTC2014yykfa110018)

摘　　要：目的：建立HPLC法测定西洛他唑片的含量及有关物质.方法：采用Ecosil C18色谱柱（250mm×4.6mm,5μm）,以乙腈-0.07mol/L磷酸溶液（用三乙胺调节pH值至2.5）（38∶62）为流动相;流速为1.0mL/min,检测波长为257nm,柱温30℃.结果：在该色谱条件下,主药和有关物质能较好的分离,西洛他唑在2.5~100μg/mL范围内,线性关系良好（r=0.999 9,n=7）,平均回收率为101.95%（RSD=0.62%,n=6）,检测限为1.6ng,测得样品中的有关物质符合质量要求.结论：本方法简便、准确、可行,精密度高,可用于西洛他唑片的质量控制.To establish an RP-HPLC method for the determination of cilostazol tablets and its related substances,the separation was performed on an Ecosil C18（250mm×4.6mm,5μm）column,with the mobile phase consisting of acetonitrile-0.07mol/L phosphate acid solution（adjusted to pH 2.5with triethylamine）（38∶62）.The flow rate was 1.0mL/min,the detection wavelength at 257 nm,the column temperature was 30℃.Cilostazol and its related substances were completely separated in current chromatography system with a good linear range of 2.5-100μg/mL（r=0.999 9）;the average recovery（n=6）was101.95%;the limit of the detection was 1.6ng.The related substances met the quality requirements well.The method is simple,feasible,accurate and specific.It can be used for quality control of cilostazol tablets.

关 键 词：西洛他唑 反相高效液相色谱法 含量测定 有关物质 

分 类 号：R927.2[医药卫生—药学]