HPLC法测定盐酸丁卡因滴眼液中羟苯乙酯的含量

Determination of ethylparaben in Tetracaine Hydrochloride Eye Drops by HPLC

目的采用高效液相色谱法测定盐酸丁卡因滴眼液中抑菌剂羟苯乙酯的含量。方法色谱柱为Agilent HC-C18色谱柱（250mm×4.6mm,5μm）;流动相为0.005mol·L-1醋酸胺溶液（每1 000mL含三乙胺10mL;冰醋酸调pH5.0）-乙腈（55∶45）;检测波长为256nm;流速1.0mL·min^-1。结果羟苯乙酯质量浓度在14.31~143.12μg·mL-1范围内,与其峰面积呈良好的线性关系（r=1）,平均回收率为99.0%（RSD=1.36%）。结论该方法专属性强、测定结果准确、精密度高、线性好,适用于检测盐酸丁卡因滴眼液中羟苯乙酯的含量。

Objective To determine the contents of ethylparaben in Tetracaine Hydrochloride Eye Drops by HPLC.Method The HPLC column was Agilent HC-C18（250mm×4.6mm,5μm）.The mobile phase was 0.005mol·L-1 ammonium acetate（1 000 mL consisted of 10 mL triethanolamine,pH adjusted to 5.0 with acetic acid）-acetonitrile（55∶45）with a flow rate of 1.0mL·min^-1.The detection wavelength was 256 nm.Results A linearity between ethylparaben concentration and peak area was achieved in the range of 14.31-143.12μg·mL-1（r=1）.The average recovery was 99.0% with RSD 1.36%.Conclusion The method is reproducible,accurate and precise,which is suitable for the determination of ethylparaben as bacteriostat in Tetracaine Hydrochloride Eye Drops.