RP-HPLC法测定硫普罗宁的有关物质  

RP-HPLC determination of related substances of tiopronin

作　　者：杨海霞[1] 屈爱存[1] 刘彩霞[1] 于盛茂[1] 

机构地区：[1]山东省生物药物研究院,济南250101

出　　处：《药物分析杂志》2009年第9期1562-1564,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立反相高效液相色谱法测定硫普罗宁的有关物质,并与药品标准收载的薄层色谱法进行比较。方法:采用Dia-monsil C18(150mm×4.6mm,5μm)色谱柱,流动相为0.1%磷酸溶液-甲醇(82∶18),流速1mL·min-1,检测波长210nm,进样量20μL。结果:硫普罗宁峰与相邻杂质峰能够完全分离。硫普罗宁浓度在0.42～16.82μg·mL-1范围内与峰面积呈良好的线性关系(r=0.9999),最低检测限为0.54ng。结论:反相高效液相色谱法与薄层色谱法比较,前者优于后者。反相高效液相色谱法操作简单,能准确、快速检测硫普罗宁的有关物质,可用于硫普罗宁的质量控制。Objective：To establish an RP - HPLC method for the determination of related substances of tiopronin and to compare the HPLC method with the TLC method in the drug specification. Methods：The chromatographic column was Diamonsil C18 （150 mm×4.6 mm,5 μm）. The mobile phase consisted of 0. 1% phosphoric acid solu- tion- methanol（82： 18） at the flow rate of 1 mL · min-1. The detection wavelength was 210 rim, and the injection volume was 20 μL. Results：Tiopronin was thoroughly separated with its nearest impurity. The calibration curve was linear in the concentration range of 0. 42 - 16. 82 μg · mL -1 （ r = 0. 9999 ） for tiopronin. The detection limit of rio- pronin was 0. 54 ng. Conclusion： Tile RP - HPLC method is superior to the TLC method. The RP - HPLC method is simple, accurate and rapid, and can be used for quality control of tiopronin.

关 键 词：反相高效液相色谱法 硫普罗宁 有关物质 

分 类 号：R917[医药卫生—药物分析学]