沈小玲
SHEN Xiao-ling

• 1:广东省轻工业高级技工学校

摘要(Abstract)：

目的研究双氯芬酸钠滴眼液的杂质谱,进而分析杂质来源,寻找控制杂质的策略。方法采用高效液相色谱法分析双氯芬酸钠滴眼液的杂质谱,并比较其变化。结果双氯芬酸钠原料性质稳定,原料杂质决定于合成工艺,制剂过程中杂质谱无变化。双氯芬酸钠滴眼液中杂质易降解,其中杂质B、C需重点检测和控制。结论通过对双氯芬酸钠滴眼液杂质谱的分析可以有目的地控制一些杂质,为质量控制提供参考。
Objective To investigate the impurity profile of diclofenac sodium eye drops and develop the impurity control strategy.Methods The HPLC method was used to analyze the impurities profiling changes of diclofenac sodium eye drops.Results Diclofenac sodium were stability,the impurities can originate from the process of synthesis of raw material,the manufacture craft made no contribution to preparation.Diclofenac sodium eye drops were easily degradable,and the main degradation impurities B and C were the key targets of detection and control.Conclusions The study of the impurities profiling on the diclofenac sodium eye drops is help to the impurites control and the quality monitoring.

关键词(KeyWords)： 双氯芬酸钠滴眼液;杂质谱;有关物质;杂质溯源分析;质量控制
diclofenac sodium eye drops;impurity profile;related substances;source analysis of impurities;quality control

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 沈小玲
SHEN Xiao-ling

DOI: 10.14066/j.cnki.cn21-1349/r.2017.06.006

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