摘要
目的:建立气相色谱法测定琥珀酸多西拉敏中有关物质的方法。方法:采用毛细管气相色谱法,程序升温,色谱柱为DB-5毛细管柱(以5%苯基甲基聚硅氧烷为固定相),载气为氦气,FID检测器,测定了琥珀酸多西拉敏原料药中有关物质含量。结果:有关物质与主药分离良好,3批样品中有关物质总杂质含量均<2%,单一杂质含量均<1%,符合USP29之规定。结论:本实验建立的色谱方法灵敏、准确,可用于考察该稳定性试验过程中的杂质变化情况。
Objective： To establish a method for determination of the related substances in doxylamine succinate. Methods： The determination was performed on a DB-5 （5% phenyl-95% dimethyl polysiloxane） silica capillary column, with FID detector, Hehum as the carries gas. Results： The separation was good between the related substances and epalrestat. The contents of total impurities in 3 batches of samples were all not more than 2%, and single impurity not more than 1%, complied with USP29. Conclusion： The method is sensitive, accurate and suitable for the determination of the related substances.
出处
《中国医药导报》
CAS
2009年第34期42-44,共3页
China Medical Herald
