HPLC法测定加替沙星滴眼液中抑菌剂羟苯乙酯的含量

Determination of ethylparaben as bacteriostat in gatifloxacin eye drops by HPLC

目的建立HPLC法测定加替沙星滴眼液中抑菌剂羟苯乙酯的含量。方法采用Agilent Zorbax SB C18色谱柱;流动相为0.005 m ol.L-1醋酸胺溶液（每1 000 m l中含三乙胺10 m l,冰醋酸调节pH值至5.0）-乙腈（60∶40）;流速：1.0 m l·m in-1;检测波长：256 nm;柱温：35℃。结果羟苯乙酯在3.06~30.55 mg·L-1范围内与色谱峰面积呈良好的线性关系（r=0.999 9）,平均加样回收率为100.38%,RSD为0.7%（n=9）。结论该方法简便、准确、重复性好,适用于检测加替沙星滴眼液中抑菌剂羟苯乙酯的含量测定。

Aim To establish the HPLC method for determination of ethylparaben as bacteriostat in gatifloxacin eye drops.Methods The HPLC column was Agilent Zorbax SB C18.The mobile phase was 0.005 mol·L-1 ammoniom acetate solution（1 000 ml consisted of 10 ml triethanolamine,and pH was adjusted to 5.0 with glaciao acetic acid）-acetonitrile（60∶40）with the flow rate of 1.0 ml·min-1.The detection wavelength was at 256 nm,and the temperature of column is 35℃.Results A linearity between ethylparaben concentration and peak area was achieved in the range of 3.06～30.55 mg·L-1（r=0.999 9）.The average recovery（n=9）was 100.38%,RSD being 0.7%.Conclusion The method is convenient,accurate and good repeatable,which is suitable for the determination of ethylparaben as bacteriostat in gatifloxacin eye drops.