Method for detecting oseltamivir phosphate genotoxic impurities

• Main Authors: YU XIUZHEN, MA XIAOYAN, YE XIAOJUN
• Format: Patent
• Language: Chinese; English
• Published: 14.05.2024
• Subjects: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES; MEASURING; PHYSICS; TESTING

The invention discloses a method capable of effectively separating and detecting a plurality of oseltamivir phosphate potential genotoxic impurities, and chromatographic conditions are as follows: a chromatographic column is an octadecyl bonded silica gel column, a phosphate buffer solution-acetonitrile is used as a mobile phase for gradient elution, an ultraviolet detector is used as a detector, and the detection wavelength is 250nm. The effective separation of the oseltamivir phosphate genotoxic impurities is accurately realized, and a simple and reliable method is provided for the detection of the oseltamivir phosphate genotoxic impurities. 本发明公开了一种能够有效分离与检测多个磷酸奥司他韦潜在基因毒性杂质的方法，色谱条件为：色谱柱为十八烷基键合硅胶柱，以磷酸盐缓冲液-乙腈为流动相进行梯度洗脱，以紫外检测器为检测器，准确地实现了磷酸奥司他韦基因毒性杂质的有效分离，为磷酸奥司他韦基因毒性杂质的检测提供了简单可靠的方法。