青蒿素哌喹片杂质的初步研究

目的：对青蒿素哌喹片中主要杂质进行初步研究。方法：采用HPLC法，以Shim-pack VP-ODS C₁₈（4.6 mm×150 mm，5 μm）为分析柱；乙腈-水（50：50）为流动相，流速为1.0 mL·min^-1；检测波长为210 nm。采用LC-MS/MS高分辨质谱对其主要杂质进行结构研究并进行溯源。结果：主峰与各杂质分离良好，检测出4个主要杂质，对其中3个主要杂质进行了定性研究，为其工艺和质量控制提供了参考依据。结论：青蒿素哌喹片对酸、碱、热、光照不稳定，因而在本品生产及贮藏时应尽量避免光照及高温，防止药品发生降解。

Objective: To study the major impurities of artemisinin and piperaquine tablets. Methods: HPLC method was employed.Shim-pack VP-ODS C₁₈ (4.6 mm×150 mm,5 μm) column was used,the mobile phase was composed of acetonitrile-water(50:50).The flow rate was 1.0 mL·min^-1.The detection wavelength was 210 nm.High resolution LC-MS/MS was employed to identify the main impurities. Results: Main peak and impurities were separated well under the established HPLC condition.Four impurities were detected,and three of them were characterized by TOF/MS. Conclusion: The artemisinin and piperaquine tablets were unstable in the acid,alkali,illumination and thermal environment,so thermal and illumination conditions should be avoided during manufacturing and storage process in case of degradation.

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