胍丁胺原料药及其有关物质的高效薄层色谱法检查  

Determination of agmatine and its related substances by high performance thin layer chromatography

作　　者：娄艳红[1] 魏君[1] 张淑珍[1] 

机构地区：[1]军事医学科学院毒物药物研究所,北京100850

出　　处：《国际药学研究杂志》2012年第5期430-432,436,共4页Journal of International Pharmaceutical Research

摘　　要：目的建立一种简便、高效的胍丁胺原料药及有关物质的高效薄层色谱(TLC)检查新方法。方法详细考察了薄层硅胶板的材质、展开剂的种类及配比、显色方法及最大上样量等因素对胍丁胺及3种相关物质分离的影响。最终选择甲醇:正己烷∶冰醋酸∶氨水(1.0∶1.0∶0.2∶1.0)为展开剂,碘熏显色。结果 3种有关物质的检出限量分别为丁二胺0.075%,S-甲基异硫脲0.9%,丁二胍0.075%。结论采用TLC可以将3种有关物质的检出限量控制在1.0%以内,本方法简便,快速,可用于硫酸胍丁胺原料药生产工艺质量控制。Objective To establish a convenient and high performance assay for determination of agmatine and its related sub- stances. Methods The effects of different quality of silica gel thin layer plate, composition and ratio of developing solvents, staining method and the maximum sample volume on separation of agmatine and three related substances on thin layer chromatography （TLC） were investigated in datail. The developing solvent of methanol： n-hexane： glacial acetic acid： ammonia solution （ 1.0： 1.0： 0. 2： 1.0） was chosen. The iodine fuming was used as color developing agent. Results The detectabilities of the three related substances of ag- matine were 0. 075% for butanediamine, 0.9% for S-methylisothiourea and 0. 075% for buformin. Conclusion The detectabilities of the three related substances of agmatine could be controlled within 1.0% by this TLC method ; furthermore, this method could be used to control productive technology of agmatine substance.

关 键 词：胍丁胺 有关物质 薄层色谱 碘熏显色 

分 类 号：R927.2[医药卫生—药学]