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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 analyze the structure of the major photodegraded cilandiosin photodegradation. Methods: HPLC-QTOF-MS was used to conduct mass spectrometric analysis of photodegraded impurities. After the structure was confirmed, the impurities were synthesized and the structures of the synthesized impurities were confirmed by NMR. The UV spectra of the synthesized and photodegraded impurities , Liquid chromatographic retention time and secondary mass spectrometry data. Results: It was further confirmed that the photodegradable impurity was ciliadipine Z-isomer. The photodegradation of cilnidipine tablets and capsules was also confirmed to be ciletidine Z-isomer. Conclusion: This study has a reference effect on the analysis of cinnabini and its impurities, quality control.