氟罗沙星注射液中高分子杂质测定

Determination of high molecular weight impurities in fleroxacin injection

目的建立氟罗沙星注射液中高分子杂质的高效液相测定方法。方法采用Sephadex G-10(10.0mm×300 mm)凝胶柱,流动相A为0.003mol.L-1磷酸盐缓冲液,用以分析样品溶液;流动相B为0.5mol.L-1磷酸盐缓冲液,用以分析对照品溶液。检测波长260 nm,流速为0.7ml.min-1。按峰面积以外标法计算样品中高分子杂质的含量。结果方法的定量限为40μg.L-1,氟罗沙星注射液中高分子杂质含量随光照时间增加。结论方法准确可靠,可用于该品种的质量控制。

Aim To establish the method for determination of high molecular weight impurities in fleroxacin injection.Methods The gel column was Sephadex G-10（10.0 mm×300 mm）,phosphate buffer（0.003 mol·L-1）as mobile phase A,with which sample solutions were analyzed;phosphate buffer（0.5 mol·L-1）as mobile phase B,with which reference solutions were determined.The detection wavelength was 260 nm and the flow rate was 0.7 ml·min-1.High molecular weight impurities in samples were calculated with area of peaks by external standard method.Results The limit of quantitation was 40 μg·L-1.Amount of high molecular weight impurities increased with light exposure.Conclusion The method was reliable,accurate and can be applied to the quality control of the preparation.