HPLC法测定恩诺沙星的有关物质

Determination of Related Substances in Enrofloxacin by HPLC

关键词:  恩诺沙星  氟喹啉酸  环丙沙星  有关物质  HPLC  质量控制

Key words:  Enrofloxacin, Fluoroquinolonic Acid, Ciprofloxacin, Related Substances, HPLC  Quality Control

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。

Abstract:

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.