RP-HPLC法测定盐酸洛美沙星可溶性粉的含量及有关物质

Determination of Lomefloxacin Hydrochloride and its Related Substances in Loreeftoxacin Hydrochioride Soluble powder by RP-HPLC

采用RP-HPLC法测定盐酸洛美沙星可溶性粉含量。色谱柱lichospher C18柱(250×4.6mm,5um);以枸橼酸液(0.05mol/L)-醋酸铵液(1mol/L)-乙腈(77∶1∶17)为流动相,检测波长为287nm。结果表明在20~200ug/m L的范围内,洛美沙星与峰面积分值呈良好的线性关系(r=0.9999),平均回收率为99.9%(n=9)。方法重复性好,准确度高,专属性强,适用于盐酸洛美沙星可溶性粉质量控制。

Objective:To establish a RP-HPLC method for determination the content of lomefloxacin hydrochloride and its related substances in lomefloxacin hydrochloride Soluble powder.Method:the lichospher C18 column(250 mm×4.6 mm,5 um)was used;the mobile phase was 0.05 mol L/L citric acid solution—ammonium acetate(1mol/L)-acetonitrile(77:1:17);the detection wavelength Was287 nm.Result:the linear range of Lomefloxacin hydroxide was20-200ug/ml,(r=0.9999);the mean recovery Was 99.9%(n=9).Conclusion:The method is sensitive,accurate and rapid.It is suitable for quality control of lomefloxacin hydrochloride Soluble powder.