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.
出处
《西南师范大学学报（自然科学版）》
CAS
北大核心
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)
