5-硝基糠醛二乙酸酯国家标准物质降解杂质研究  

Degradation Impurities Study of National Reference Standards of 5-Nitro-2-Furaldehyde Diacetate

作　　者：杨青 田冶[1] 张夏[1] 刘颖[1] 尹利辉[1] YANG Qing;TIAN Ye;ZHANG Xia;LIU Ying;YIN Li-hui(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国药学杂志》2021年第23期1949-1952,共4页Chinese Pharmaceutical Journal

基　　金：化学药品质量研究与评价重点实验室科研项目资助(1030050090119)。

摘　　要：目的对5-硝基糠醛二乙酸酯国家标准物质长期放置产生的降解杂质的结构和来源进行研究。方法采用高效液相色谱(HPLC)法和高效液相-高分辨质谱(HPLC-HRMS)法对长期放置的5-硝基糠醛二乙酸酯国家标准物质产生的相关杂质的结构进行研究,通过影响因素实验(高温、高湿、光照)进一步探讨降解杂质产生的途径。结果长期放置的5-硝基糠醛二乙酸酯国家标准物质降解的主要杂质为5-硝基糠醛,影响因素试验研究表明,高温是其降解的主要因素。原有的棕色西林瓶包装,在高湿条件下没有起到保护作用,在光照射条件下起到了一定的保护作用。结论5-硝基糠醛二乙酸酯不稳定,易受到外界条件的影响,在研制国家标准物质时应注意包装的选择和储藏条件。OBJECTIVE To study the structure and source of degradation impurities of national reference standards of 5-nitro-2-furaldehyde diacetate.METHODS Firstly,high performance liquid chromatographic method(HPLC)and high performance liquid-high resolution mass spectrometry(HPLC-HRMS)were adopted to analyze the impurities structure of national reference standards of 5-nitro-2-furaldehyde diacetate stored for long time.Furthermore,the degradation pathways of impurities was further explored through the stress testing(high temperature,high humidity,and light).RESULTS The major impurity of long-term storage national reference standards of 5-nitro-2-furaldehyde diacetate was 5-nitro-2-furaldehyde.The results of stress testing showed that high temperature was the main factor of degradation.The packaging of brown sill in Xilin bottle had no protective effect in high humidity,but had certain protective effect under the strong light.CONCLUSION The 5-nitro-2-furaldehyde diacetate is unstable and susceptible to external conditions.In the development of national reference materials,attention should be paid to the selection of packaging and storage conditions.

关 键 词：国家标准物质 5-硝基糠醛二乙酸酯 降解杂质 影响因素试验 

分 类 号：R917[医药卫生—药物分析学]