西尼地平光降解杂质的结构分析

目的：对西尼地平的主要光降解杂质进行结构分析。方法：采用HPLC-QTOF-MS联用技术对光降解杂质进行质谱分析，初步确认结构后定向合成该杂质并通过核磁共振技术对合成杂质进行结构确认，并比对合成杂质和光降解杂质的紫外光谱、液相色谱保留时间和二级质谱数据。结果：进一步确认该光降解杂质为西尼地平Z-异构体；并同时确认西尼地平片及胶囊的光降解杂质均为西尼地平Z-异构体。结论：本研究对西尼地平及其制剂杂质分析、质量控制具有参考作用。

Objective: To identify the major light degradation impurity of cilnidipine.Methods: HPLC-QTOFMS was adopted to preliminarily analyze the structure of the impurity.The impurity was then synthesized and its structure was further identified by NMR.Then we compared the mass spectra,UV spectra and retention time of this synthesized impurity with the light degradation impurity.Results: The light degradation impurity was confirmed to be Z-isomer of cilnidipine.In addition,the chemical structure of the major light degradation impurity of cilnidipine tablet and capsule was also confirmed to be Z-isomer of cilnidipine.Conclusion: The research offers scientific data for studying the impurities of cilnidipine and its preparations and the related quality control.

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