摘要
根据盐酸昂丹司琼不同的合成路线,分析了产品中可能存在的原料、中间体、副产物及降解产物等5 种杂质。对杂质2~5 采用氰基柱反相HPLC进行检查,杂质6 采用TLC进行限度检查。
According to different synthetic routes a decomposition product 2 and four impurities 3, 4, 5, 6 were present in ondansetron hydrochloride. They were determined by RP HPLC and TLC. In five samples 2 was detected (less than 0.1%), other impurities were not detected.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
1999年第7期313-315,共3页
Chinese Journal of Pharmaceuticals
关键词
盐酸昂丹司琼
降解产物
杂质
测定
ondansetron hydrochloride, decomposition product, impurity, HPLC, TLC, determination