摘要
In the present study,we analyzed the structures of the two unknown impurities that were contained more than 0.1% in triamcinolone acetonide palmitate by using HPLC-DAD and HPLC-MS hyphenated techniques,and these impurities were synthesized and purified by column chromatography.Based on the results of NMR spectroscopy,IR spectroscopy,and MS,the two impurities were confirmed as 9-fluoro-11β,21-dihydroxy-16α,17-(isopropylidenedioxy)pregna-1,4-diene-3,20-dione 21-myristate and stearate,respectively.
利用HPLC-DAD和HPLC-MS联用技术对棕榈酸曲安奈德中含量超过0.1%的未知杂质进行结构分析,合成杂质后通过柱色谱法进行纯化。根据NMR、IR和MS的结果,确定这两种杂质分别为9-氟-11β,21-二羟基-16α,17-异丙基双氧孕甾-1,4-二烯-3,20-二酮21-肉豆蔻酸酯和硬脂酸酯。