LC-MS-IT-TOF法研究阿戈美拉汀及其片剂中的杂质

Study on the impurity of Agomelatine and its tablets by LC-MS-IT-TOF

目的研究阿戈美拉汀及其片剂中的杂质。方法采用高效液相色谱-离子阱-飞行时间质谱联用法(LC-MSIT-TOF)测定有关物质,根据质谱测定结果并结合合成工艺路线,推测杂质的结构。结果推测可能的杂质结构分别为N,N-二乙酰基-2-(7-甲氧基萘-1-基)乙胺、N-丙酰基-2-(7-甲氧基萘-1-基)乙胺、阿戈美拉汀的二聚体、N,N-2-(7-甲氧基萘-1-基)乙酰胺、2-(7-甲氧基萘-1-基)乙胺、2-(7-羟基萘-1-基)乙酰胺。结论推测了6种杂质的结构及可能的来源,为阿戈美拉汀的质量控制及生产和贮存提供了重要的参考依据。

OBJECTIVE To investigate the impurities in Agomelatine and its tablets. METHODS The products were determined by LC - MS - IT - TOF. The structure of impurities were elucidated by the results of mass spectrometry combined with the synthetic process route. RESULTS The possible impurities structure were N, N - diaeetyl - 2 - （7 - methoxy - naphthyl） ethylamine,N, propi- onyl - 2 - （ 7 - methoxy - naphthyl） ethylamine, a dimmer of Agomelatine, N, N - 2 - （ 7 - methoxy - naphthyl ） acetamide and 2 - （ 7 - methoxy - naphthyl） ethylamine and 2 - （ 7 - hydroxy - naphthalene） acetamide. CONCLUSION Six impurities of Agomelatine and its possible source have been speculated, which provide an important reference for its quality control production and storage.