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目的通过方法筛选,建立注射用氟氧头孢钠有关物质检查方法。方法色谱条件为磷酸盐缓冲液:甲醇(75:25),调整流速主峰出峰时间为9min,系统适用性应符合规定,保留时间应为主峰出峰时间的7倍。结果供试品溶液不稳定,需现配现进样;检测限为35ng/ml;专属性降解产物主要为1-(2-羟乙基)-1氢-四唑-5-硫醇。结论所建立有关物质方法可有效控制产品质量,方法可行。
Objective To establish a method for the determination of related substances of Foxyloxacin for injection by screening methods. Methods Chromatographic conditions were phosphate buffer solution: methanol (75:25). The peak flow time of the main flow was adjusted to 9 min, and the system applicability should be in accordance with the regulations. The retention time should be 7 times the peak time of the main peak. The results for the test solution instability, the need to be equipped with the current injection; detection limit of 35ng / ml; proprietary degradation products mainly 1- (2-hydroxyethyl) -1 hydrogen-tetrazole -5-thiol. Conclusion The method of establishing the relevant substances can effectively control the quality of products, the method is feasible.