HPLC法测定恩诺沙星的有关物质  

Determination of Related Substances in Enrofloxacin by HPLC

作　　者：于晓辉[1] 杨星[1] 王雷[1] 马秋冉 季璇 汪霞[1] YU Xiao-hui;YANG Xing;WANG Lei;MA Qiu-ran;JI Xuan;WANG Xia(China Institute of Veterinary Drug Control,Beijing 100081,China)

机构地区：[1]中国兽医药品监察所(农业农村部兽药评审中心),北京100081

出　　处：《中国兽药杂志》2025年第2期13-22,共10页Chinese Journal of Veterinary Drug

摘　　要：采用HPLC梯度洗脱双波长测定法,新建了一种可以同时测定氟喹啉酸、环丙沙星及其他杂质的恩诺沙星有关物质测定方法。通过筛选测定波长、溶剂、进样浓度,对新建方法进行了优化。通过考察专属性、准确度、线性、检测限、定量限、精密度、溶液稳定性、耐用性,对新建方法进行了验证。实验结果表明,新建方法准确、可靠,适用于恩诺沙星有关物质的质量控制。A new method using gradient elution and dual-wavelength of HPLC was established to determine simultaneously fluoroquinolonic acid,ciprofloxacin and other related substances in enrofloxacin.The new method was optimized by screening wavelength,solvent and injection concentration.The new method was verified by investigating the specificity,recovery,linearity,LOD,LOQ,precision,stability of solution and durability of the method.The experimented results show that the new method is accurate and reliable,and is suitable for the quality control of related substances in enrofloxacin.

关 键 词：恩诺沙星 氟喹啉酸 环丙沙星 有关物质 HPLC 质量控制 

分 类 号：S859.79[农业科学—临床兽医学]