中国药典和欧洲药典甲磺酸培氟沙星有关物质检测方法的比较

Comparison of the methods for the related substances control of pefloxacin mesylate in Chinese and/or European Pharmacopoeias

目的通过比较中国药典(ChP)和欧洲药典(EP)中甲磺酸培氟沙星有关物质检测方法的检测能力,结合对有关物质测定结果的比较,对两种检测方法进行评价。方法分别采用ChP和EP所收载的甲磺酸培氟沙星有关物质分析方法,对甲磺酸培氟沙星注射剂有关物质进行测定,对其色谱行为、有关物质测定结果、杂质的检出数量和实验成本等进行比较,进行综合评价。结果ChP与EP方法液相色谱行为差别较大,两种方法测定甲磺酸培氟沙星的最大杂质和总杂质含量相当,ChP检出的杂质个数多于EP,系统分离度优于EP。结论中国药典方法优于欧洲药典,能够有效控制国产产品的有关物质。

Objective Different HPLC methods ofrelated substances of pefloxacinmesylate in Chinese Pharmacopoeia （ChP） and European Pharmacopoeia （EP）were compared, and the results of the related substances were compared to evaluate the methods. Methods The analysis methods of pefloxacin mesylate contained in ChP and EP were employed to determine the related substances of pefloxacin mesylate for injection.The methods were comprehensively evaluated regarding the chromatographic features, determination results, the number of impurities, and experimental costs of each method. Results The chromatographic features of two methods were quite different. The maximum impurity and total impurities contents ofpefloxacin mesylate injections determined by the two methods were equivalent, but the method in ChP detected more impurities than that in EP, and the HPLC system resolution of ChP was better than EP. Conclusion The method in ChP is superior to that in EP, and can be used to control the related substances ofpefloxacin mesylate injections effectively.