中国药典和欧洲药典盐酸万古霉素有关物质检测方法的比较研究

Comparative Study on Determination Methods of Vancomycin Hydrochloride Chinese Pharmacopoeia and European Pharmacopeia

目的比较并讨论《中国药典》和《欧洲药典》中盐酸万古霉素有关物质的检测方法,为完善盐酸万古霉素及注射用盐酸万古霉素有关物质的检测方法提供科学依据。方法采用《中国药典》2020年版(ChP2020)和《欧洲药典》10.0版(EP10.0)有关物质方法,分别对系统适用性试验、空白辅料干扰试验、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。结果两种药典方法中色谱条件、系统适应用性要求和杂质控制策略存在较大差异。EP方法对特定杂质的分离效能优于ChP,且样品中检测出的杂质数量大于或等于ChP,但两种药典方法检测得到的总杂质含量结果无明显差异。结论建议测定盐酸万古霉素及注射用盐酸万古霉素有关物质时推广使用EP10.0中的有关物质检测方法。

Objective To compare and discuss the determination methods of vancomycin hydrochloride related substances in Chinese Pharmacopoeia(ChP)and European Pharmacopeial(EP),so as to provide the scientific basis for the determination of related substances in vancomycin hydrochloride and vancomycin hydrochloride for injection.Methods The vancomycin hydrochloride related substances were determined by adopting the methods of related substances quality standard contained in ChP2020 and EP10.0.The system suitability,blank excipient interference test,forced degradation and samples were tested.Comparisons were made between the chromatographic behavior,known impurities,associated compounds determination results,and impurity control technique.Results The chromatographic conditions,system applicability requirements and impurity control strategy of two methods have a large difference.The EP approach was more effective than ChP at separating particular impurities,and the levels of impurities found in the samples were greater than or on par with those found in Chp.However,there was no significant difference in the total contents of impurity between the two pharmacopoeia methods.Conclusion It is suggested that EP10.0 should be widely used in the determination of vancomycin hydrochloride and vancomycin hydrochloride for injection.