高效液相色谱法测定匹多莫德片的含量及有关物质  

Determination of the Contents of Pidotimod and Its Related Substances in the Tablet Products by HPLC

作　　者：王建[1] 张翼[1] 李毓[1] 杜亚俊 陈红[1] 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：《西南大学学报（自然科学版）》2015年第12期178-184,共7页Journal of Southwest University(Natural Science Edition)

基　　金：国家自然科学基金青年项目资助(2140216);重庆市应用开发项目资助(CSTC2014yykfa110018)

摘　　要：目的：建立HPLC法测定匹多莫德片的含量及有关物质.方法：采用Ecosil C18色谱柱（250 mm×4.6 mm,5μm）,以0.01moL/L磷酸二氢钠溶液-甲醇-异丙醇（97∶2∶1）为流动相;流速为1.0 mL/min,检测波长为210nm,柱温25℃.结果：在该色谱条件下,主药匹多莫德与相邻杂质峰的分离度大于1.5,且匹多莫德、杂质X、杂质Y均能够完全分离;匹多莫德线性范围为270-630μg/mL（r=0.999 9,n=5）,平均回收率为98.79%（RSD=0.49%,n=9）,检测限为3.125ng.结论：该方法简便、准确、可行,适用于匹多莫德片的质量控制。An HPLC method for the determination of pidotimod and its related substances in the tablet products was developed in a study reported herein.The separation was performed on an Ecosil C18（250mm×4.6mm,5μm）column with the mobile phase consisting of 0.01mol/L sodium dihydrogen phosphate-methanol-isopropanol（97∶2∶1）.And the flow rate was 1.0mL/min,the detection wavelength was 210 nm and the column temperature was 25 ℃.The resolution between pidotimod and the related substances was greater than 1.5and,especially,pidotimod,impurity X and impurity Y were completely separated with the proposed method.A good linear relationship existed within the range of 270-630μg/mL（r=0.999 9）.The average recovery was 98.79%（RSD =0.49%）.The limit of the detection was 3.125 ng.In conclusion,the method described above is simple,accurate and feasible,and can be used for quality control of pidotimod tablets.

关 键 词：匹多莫德 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]