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.
出处
《西南大学学报（自然科学版）》
CAS
CSCD
北大核心
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)
作者简介
王建（1989-），男，湖北洪湖人，硕士研究生，主要从事药物分析方面的研究．
通信作者：袁吕江，教授，研究生导师．
