HPLC法测定盐酸莫西沙星有关物质

Determination of related substances in moxifloxaxin hydrochloride by HPLC

目的建立高效液相色谱法测定盐酸莫西沙星原料有关物质。方法采用Inertsil Phenyl柱苯基键合硅胶(4.0 mm×250 mm,5μm)色谱柱,以四丁基硫酸氢铵缓冲液-甲醇为流动相,梯度洗脱,流速1.3 mL/min,柱温50℃,检测波长293 nm。结果盐酸莫西沙星与15个已知杂质A~O均能良好分离。6个厂家盐酸莫西沙星样品测定结果显示,已知杂质及其他最大单个杂质含量均小于0.05%,杂质总含量小于0.06%。结论本方法灵敏、专属性强,准确度高,可用于盐酸莫西沙星原料药有关物质测定。

Objective To establish an HPLC method for method for the determination of the related substances in moxifloxacin hydrochloride.Methods The determination was performed on a phenyl column(4.0 mm×250 mm,5μm).The mobile phase consisted of tetrabutyl ammonium bisulfate buffer solution and methanol with gradient elution.The flow rate was 1.3 mL/min,and the column temperature was maintained at 50℃,the detection wavelength was set at 293 nm.Results The resolutions between the peaks of moxifloxacin hydrochloride and fifteen known impurities(including impurities A~O)were good.The determination results of the six batches of moxifloxacin hydrochloride samples showed that the known impurities and the maximum single unknown impurity were less than 0.05%,and the total impurity was less than 0.06%.Conclusion The method is proved to be simple,accurate,and could be used for the determination of related substances in moxifloxacin hydrochloride.