盐酸柔红霉素中未知杂质的鉴定、分离与表征

A. Rawat, V. Buchude, K. Chauhan, Divyesh Patel, Ritesh G. Patel, Chandrakant Belwal, A. Vardhan
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引用次数: 4

摘要

采用反相等容高效液相色谱法对原料药盐酸柔红霉素中RRT值为1.79的未知杂质进行了检测。该杂质被分离、富集并进行了质谱和核磁共振谱研究。根据光谱数据鉴定该杂质为(8S,10S)-8-乙基-10-((2S,4S,5S,6S)-4-氨基-5 -羟基-6-甲基-氧-2-基)氧-6,8,11-三羟基-1-甲氧基-9,10-二氢- 7h -四烯-5,12-二酮,又称13-脱氧柔红霉素。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Identification, Isolation and Characterization of Unknown Impurity in Daunorubicin Hydrochloride
An unknown impurity in the bulk drug daunorubicin hydrochloride observed at 1.79 RRT was detected by the means of reverse phase isocratic High performance liquid chromatography (HPLC). This impurity was isolated, enriched and was subjected to mass and NMR spectral studies. Based on the spectral data the impurity was identified as (8S,10S)-8-ethyl-10-((2S,4S,5S,6S)-4-amino- 5-hydroxy-6-methyl-oxan-2-yl)oxy-6,8,11-trihydroxy-1-methoxy-9,10-dihydro-7H-tetracene-5,12- dione also known as 13-deoxy-daunorubicin.
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