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Identification of unknown impurities in triamcinolone acetonide palmitate

棕榈酸曲安奈德中未知杂质的鉴定
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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。
作者 Xiangfei Jin Minyue Cheng Sihui Zhong Yungen Xu Weiyang Shen 金祥飞;程闽玥;钟斯卉;徐云根;沈卫阳(中国药科大学理学院分析化学教研室,江苏南京211198;中国药科大学药物化学系江苏省药物设计与优化重点实验室,江苏南京211198;药物质量与安全预警教育部重点实验室,江苏南京210009)
出处 《Journal of Chinese Pharmaceutical Sciences》 CAS CSCD 2022年第4期270-278,共9页 中国药学(英文版)
关键词 Triamcinolone acetonide palmitate Impurity identification HPLC-DAD LC-MS 棕榈酸曲安奈德 杂质鉴定 HPLC-DAD LC-MS
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