盐酸伊达比星杂质A的合成工艺优化及其高效液相分析  

Optimized Synthesis of Impurity A of Idarubicin Hydrochloride and Its HPLC Analysis

作　　者：苏进财 黄丹丹 代清宇 季晓君 吴舰 徐丹 SU Jincai;HUANG Dandan;DAI Qingyu;JI Xiaojun;WU Jian;XU Dan(Nanjing Chia-tai TianQing Pharmaceutical Co.,Ltd.,Nanjing 210046,China)

机构地区：[1]南京正大天晴制药有限公司,江苏南京210046

出　　处：《合成化学》2022年第10期834-838,共5页Chinese Journal of Synthetic Chemistry

基　　金：江苏省自然科学基金(青年)资助项目(BK20210055)。

摘　　要：通过对盐酸伊达比星脱羟基杂质A的合成研究,为盐酸伊达比星的质控标准提供参考。以盐酸伊达比星为起始原料,经过4步反应得到脱羟基杂质A。本文提供了盐酸伊达比星杂质A的制备方法以及高效液相色谱分析方法,为杂质含量控制提供了依据。该工艺可以稳定、快速地制备高纯度脱羟基杂质A,制备总收率为57.20%,纯度为99.80%,其结构经^(1)H NMR,^(13)C NMR和MS(ESI)表征。The research on the synthesis of idarubicin hydrochloride dehydroxylated impurity A provides a reference for the quality control standard of idarubicin hydrochloride.Using idarubicin hydrochloride as raw material,dehydroxylated impurity A was synthesized by four steps reactions.In this paper,the preparation method and HPLC analysis method are provided,which provides the basis for impurity control.This process can prepare high purity dehydroxylated impurity A stably and quickly.The total yield was 57.20%,the purity was 99.80%,and the structures were characterized by ^(1)H NMR,^(13)C NMR and MS(ESI).

关 键 词：盐酸伊达比星 脱羟基的杂质A 合成 制备方法 高效液相分析方法 

分 类 号：O625.46[理学—有机化学] R914.5[理学—化学]