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目的对依巴斯汀主要未知杂质的结构进行鉴定,为降低杂质含量及合成工艺改进提供技术支撑,并提高产品质量。方法采用制备液相色谱从依巴斯汀原料中制备得到主要未知杂质,通过EI质谱、核磁共振、红外光谱和紫外光谱对杂质的结构进行鉴定,并根据鉴定结果,用市售的试剂进行结构确认。结果依巴斯汀中的主要未知杂质确证为对称四苯乙烷。结论主要未知杂质为依巴斯汀合成副产物,为依巴斯汀的质量控制和工艺优化提供参考依据。
OBJECTIVE To identify the structure of major unknown impurities of ebastine, to provide technical support for reducing the impurity content and improving the synthetic process, and to improve product quality. Methods The major unknown impurities were obtained from ebastine raw materials by preparative liquid chromatography. The structures of impurities were identified by EI-MS, 1H-NMR, IR and UV spectra. Based on the identification results, confirm. Results The major unknown impurity in ebastine was confirmed to be symmetrical tetraphenylethane. Conclusion The major unknown impurities are by-products of Bastin synthesis, which provide reference for the quality control and process optimization of ebastine.