高效液相色谱法同时测定加替沙星滴眼液中加替沙星和羟苯乙酯的含量

Simultaneous determination of gatifloxacin and ethylparaben in gatifloxacin eye drops by HPLC

目的建立高效液相色谱法(HPLC)同时测定加替沙星滴眼液中加替沙星和羟苯乙酯的含量。方法采用Zorbax XDB-C18色谱柱(4.6 mm×150 mm,5μm),以乙腈-0.1%磷酸溶液(60:40)为流动相,流速1.0 ml/min,检测波长256 nm,柱温:35℃。结果加替沙星浓度在2.98~29.8μg/ml范围内与线性关系良好(r=0.9998),平均加样回收率为99.03%,相对标准偏差(RSD)为0.86%(n=6);羟苯乙酯浓度在3.26~32.6μg/L范围内线性关系良好(r=0.9999),平均加样回收率为99.44%,RSD为1.02%(n=6)。结论 HPLC操作简便快捷,结果准确,重现性好,可同时测定加替沙星和羟苯乙酯的含量,为该制剂的质量控制提供参考。

Objective To develop a HPLC method for the simultaneous determination of gatifloxacin and ethylparaben in gatifloxacin eye drops.Methods The PHLC was performed on Zorbax XDB-C18 column（4.6 mm×150 mm,5μm）.The mobile phase consisted of acetonitrile-0.1% phosphoric acid（60：40）.The flow rate was 1.0 ml/min and the detection wavelength was 256 nm.Results The linear range of gatifloxacin was 2.98 ~ 29.8 μg/ml（r=0.9998）,the average recovery was 99.03%（n=6）;The linear range of ethylparaben was 3.26~32.6 μg/L（r=0.9999）, the average recovery was 99.44%（n=6）.Conclusion HPLC is simple,accurate and repeatable.It can be applied to controlling the quality of gatifloxacin eye drops.