HPLC法测定硝克柳胺的含量及有关物质  

DETERMINATION OF CONTENTS OF NICOUSAMIDE AND RELATED SUBSTANCES BY HPLC

作　　者：王乐[1] 王娅莉[2] 赵玉[2] 牛长群[2] 郭丽[3] 

机构地区：[1]河北化工医药职业技术学院制药工程系药物制剂教研室,河北石家庄050026 [2]华北制药集团新药研究开发有限责任公司仪器分析研究室,河北石家庄050015 [3]河北医科大学第四医院药品科,河北石家庄050011

出　　处：《河北医科大学学报》2013年第3期302-305,共4页Journal of Hebei Medical University

摘　　要：目的建立硝克柳胺含量和有关物质的高效液相色谱(high performance liquid chromatography,HPLC)测定方法。方法采用Inertsil C_8柱(250mm×4.6mm,5μm,GL Sciences Inc.);流动相为水-乙腈-四氢呋喃(50:50:1)(内含0.1%磷酸);流速为1.0mL/min;检测波长为330nm;柱温为30℃。结果在选定色谱条件下,主峰与有关物质峰分离度良好,硝克柳胺在0.02～1.0g/L浓度范围内线性关系良好(r=0.999 6);平均回收率为100.1%(n=9);检测限为0.1ng。结论该方法专属性强、灵敏度高、操作简便,可用于测定硝克柳胺的含量及有关物质。Objective To establish an high performance liquid chromatography（HPLC） method for determination of nicousamide and its related substances. Methods The separation was performed on an Inertsil Cs （ 250mm × 4.6mm,5 μm, GL Sci.ences Inc. ） column with the mobile phase consisting of water-acetonitrile-tetrahydrofuran （50： 50：1 ） （ including 0.1% phosphoric acid ） at the flow rate of 1.0mL/min. The detection wavelength was set at 330nm. The column temperature was 30℃. Results Under the above conditions, the main peak and the peaks of the related substances were separated quite well. Nicousamide had a good linear relationship （ r = 0. 999 6 ） within the range of 0.02 - 1. 0g/L. The average recovery （n =9 ） was 100.1%. The limit of detection was 0. lng. Conclusion The method is sensitive, specific and simple. It can be used for determinating nicousamide and its related substances.

关 键 词：硝克柳胺 色谱法 高压液相 研究设计 

分 类 号：R917[医药卫生—药物分析学]