High performance liquid chromatography for efficiently separating and detecting related substances in D-serine

The invention provides a high performance liquid chromatography for efficiently separating and detecting related substances in D-serine, the D-serine can be used as a starting material of a plurality of medicines such as lacosamide, the quality of a final product and the medication safety of a patie...

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Bibliographische Detailangaben
Hauptverfasser: ZHAO NA, NIU YULE, LIU MEIXIA, DENG SHENGJU, WANG HONG, ZHANG LI, ZHOU MEIJING
Format: Patent
Sprache:chi ; eng
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Zusammenfassung:The invention provides a high performance liquid chromatography for efficiently separating and detecting related substances in D-serine, the D-serine can be used as a starting material of a plurality of medicines such as lacosamide, the quality of a final product and the medication safety of a patient can be ensured by researching and controlling impurities of the D-serine, and the method has important industrial value. According to the method disclosed by the invention, a preferable hydrophilic chromatographic column is adopted, and effective separation of a plurality of compounds, such as impurities related to preparation of D-serine, dimer impurities and the like, which are difficult to separate by a conventional method is realized. 本发明提供一种高效分离并检测D-丝氨酸中有关物质的高效液相色谱法,D-丝氨酸可以作为拉考沙胺等多个药物的起始物料,对其杂质的研究与控制可以保证终产品的质量和患者用药安全,具有重要的产业价值。本发明的方法采用优选的亲水色谱柱,实现了D-丝氨酸的制备相关杂质以及二聚体杂质等多个常规方法难以分离的化合物的有效分离。