高效液相色谱法测定尼可地尔中的有关物质  

Related substances determination of nicorandil by HPLC

作　　者：李步良[1] 黄东[1] 王昉[2] 

机构地区：[1]江苏天士力帝益药业有限公司,江苏淮安223002 [2]南京师范大学分析测试中心,江苏南京210046

出　　处：《中国医药科学》2014年第2期52-54,共3页China Medicine And Pharmacy

基　　金：江苏省高校自然科学研究自筹经费项目(09KJD350001)

摘　　要：目的：建立尼可地尔中有关物质的测定方法。方法碳十八烷键合硅胶（5μm）填充4mm＆#215;25cm不锈钢柱；流动相为水：四氢呋喃：三乙胺：三氟乙酸（982∶10∶5∶3）；检测波长：254nm；流速：调整流速使尼可地尔出峰时间约为18min。结果尼可地尔与主要杂质能得到有效分离，各杂质在0.2～4.0μg/mL范围内呈良好线性关系。结论本测定方法灵敏度高，准确可靠，可以控制尼可地尔中有关物质的含量。Objective To establish a method for determination of related substances in the nicorandil. Methods The analytical column was C18 column（4.0mm＆#215;25cm,5μm）.The mobile phase was water：THF：triethylamine：trifluoroacetic acid=982∶10∶5∶3,The wave lenth was 254nm, the flow rate was adjust the flow rate of the peak time of nicorandil was about 18 minutes. Results A satisfactory separation condition for the five related impurities,the impurities standard curve was good linear over the range of 0.2~4.0μg/mL. Conclusion The method is sensitive and accurate and it can be used to determine the relateted substances of nicorandil.

关 键 词：尼可地尔 有关物质 系统适用性 

分 类 号：R917[医药卫生—药物分析学]