Preparation method of mupirocin impurity reference substance

• Main Authors: WEN JIUPING, LOU YUYANG, DING MINGYU, SHANG XUELING, GUO JING, LI XIAOFANG, ZHU XIAN, MA YAXIN, CHEN WENWEN, MA BIN, PAN QIYING, XIE YINGKAI, SUN DAN
• Format: Patent
• Language: Chinese; English
• Published: 21.12.2021
• Subjects: CHEMISTRY; HETEROCYCLIC COMPOUNDS; INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES; MEASURING; METALLURGY; ORGANIC CHEMISTRY; PHYSICS; TESTING

The invention relates to a preparation method of an impurity reference substance in mupirocin, and belongs to the technical field of pharmaceutical analysis. According to the method, a plurality of technologies such as preparative liquid chromatography, time-of-flight mass spectrometry, nuclear magnetic resonance spectrum, freeze dryer and high performance liquid chromatography are adopted to separate and purify the six mupirocin impurities A, B, C, D, E and F, freeze-drying, content detection, structure confirmation and standardization are carried out, and the six impurities can be used as impurity reference substances in quality detection of mupirocin bulk drugs and preparations. The invention provides a separation and purification method of mupirocin impurities. The method is a universal separation method of mupirocin impurity reference substances and solves the problem of lack of impurity reference substances in current mupirocin quality control and impurity research. 本发明一种莫匹罗星中杂质对照品的制备方法，属于药物分析技术领域。该方法采用