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高效液相色谱法测定司帕沙星片的有关物质
Determination of related substances in sparfloxacin tablets by HPLC
【摘要】 目的建立一种高效液相色谱法测定司帕沙星片的有关物质。方法用Diamonsil-C18色谱柱(250 mm×4.6 mm,5μm),磷酸盐溶液(取磷酸二氢钾6.8 g和三乙胺3.0 ml,加水溶解并稀释至1 000 ml,摇匀)-甲醇(43∶57)(用磷酸调节pH值至2.5)作为流动相,流速为1.0 ml.min-1,检测波长298 nm。结果司帕沙星的最低检出限为0.25 ng,司帕沙星与各杂质峰分离良好。结论该方法操作简便、专属性强,可用于司帕沙星片的质量控制。
【Abstract】 Aim To establish a HPLC method for determination of related substances in sparfloxacin tablets.Methods The HPLC method was performed on Diamonsil-C18 column(250 mm×4.6 mm,5 μm),phosphate solution(KH2PO3 6.8 g and triethylamine 3.0 ml dissolved with water to 1 000 ml,shaken)∶methanol(43∶57)(phosphoric acid adjusted to pH 2.5)as mobile phase.The flow rate was 1.0 ml·min-1,and detection wavelength was set at 298 nm.Results The detection limits for sparfloxacin was 0.25 ng.Good resolution for sparfloxacin and related substances was obtained.Conclusion The method was simple and specific,and can be used for quality control of sparfloxacin tablets.
- 【文献出处】 安徽医药 ,Anhui Medical and Pharmaceutical Journal , 编辑部邮箱 ,2007年12期
- 【分类号】R927.2
- 【被引频次】2
- 【下载频次】88