中国药典和美国药典阿莫西林有关物质检测方法的比较研究

Comparative Study on Determination Methods of Amoxicillinin Chinese Pharmacopoeia and United States Pharmacopeial Convention

目的比较并讨论中国药典和美国药典中阿莫西林有关物质的测定方法,为阿莫西林原料药有关物质检测提供科学依据。方法采用中国药典2015年版(ChP2015)和美国药典42版(USP42)收载的阿莫西林有关物质方法,分别对系统适用性混合溶液、相对响应因子试验、强制降解试验和样品进行有关物质检测,对色谱行为、已知杂质、有关物质测定结果和杂质控制策略等进行比较。结果两国药典方法中色谱条件、系统适用性要求和杂质控制策略存在较大差异,USP方法对特定杂质的分离效能优于ChP,且样品中检出的杂质数量和总杂含量均高于ChP,较ChP方法多检出一个已知杂质C,其他已知杂质含量无明显差异。结论建议在USP收载的阿莫西林有关物质方法基础上进一步优化色谱条件,提高方法的分离效能,从而更加有效控制本品的有关物质。

Objective To compare and discuss the determination methods of amoxicillin related substances in Chinese Pharmacopoeia(ChP)and United States Pharmacopeial Convention(USP),so as to provide scientific basis for the determination of related substances in amoxicillin.Methods The amoxicillin related substances were determined by adopting the methods of related substances quality standard contained in ChP2015 and USP42.The system suitability,relative response factor,forced degradation and samples were tested.The chromatographic behavior,known impurities,related substances determination results and impurity control strategy were performed the comparison.Results The chromatographic conditions,system applicability requirements and impurity control strategy of two methods have large difference.The USP method was superior to ChP in the separation efficiency of specific impurities,and the quantities and contents of impurity detected in the samples were both higher than that in ChP.Compared with ChP method,one more known impurity C was detected in USP,while there was no significant difference in other known impurities.Conclusion It is suggested to optimize the chromatographic conditions and improve the separation efficiency of amoxicillin based on the USP method,so as to control the related substances of this product more effectively.