阿卡波糖杂质对照品的制备方法

• Format: Patent
• Language: Chinese
• Published: 27.08.2024
• Subjects: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES; MEASURING; PHYSICS; TESTING

本发明公开了一种阿卡波糖杂质对照品的制备方法，属于药物分析技术领域。该方法采用制备液相色谱、紫外吸收光谱、红外吸收光谱、飞行时间质谱（TOF-MS）、核磁共振谱（NMR）、冷冻干燥机、定量核磁检测等多种技术，对阿卡波糖杂质Ⅰ、Ⅱ、Ⅲ、Ⅳ四个杂质进行了分离纯化、冷冻干燥、含量检测、结构确证和标化，这四个杂质可以在阿卡波糖原料药及制剂的质量检测中作为杂质对照品。本发明提供一种阿卡波糖杂质的分离纯化方法，该方法是一种通用的阿卡波糖杂质对照品的分离方法，可用于阿卡波糖其他有关物质的纯化制备，解决了目前阿卡波糖质量控制和杂质研究中存在的杂质对照品缺乏问题。 The invention discloses a preparation method of an acarbose impurity reference substance and belongs to the technical field of pharmaceutical analysis. According to the method, separation and purification, freeze drying, content detection, structure confirmation and standardization are carried out on the four acarbose impurities I, II, III and IV by adopting multiple technologies such as preparative liquid chromatography, ultraviolet absorption spectrum, infrared absorption spectrum, time-of-flight mass spectrum (TOF-MS), nuclear magnetic resonance spectrum (NMR), freeze dryer, quantitative nuclear magnetic detection and the like. The four impurities can be used as impurity reference substances in quality detection of acarbose raw materi