HPLC法测定氨碘肽滴眼液中羟苯甲酯、羟苯乙酯的含量

Determination of Methylparaben and Ethylparaben in Amiotide Eye Drops by HPLC

目的:建立氨碘肽滴眼液中抑菌剂羟苯甲酯、羟苯乙酯高效液相色谱法测定的方法。方法:色谱柱:Agilent Eclipse XDB-C_(18)(150 mm×4.6 mm,5μm);流动相:0.005mol/L乙酸铵溶液(称取乙酸铵0.38g,加水溶解并稀释至1000ml,加10ml三乙胺,用冰醋酸调节pH值至5.0)-乙腈(62:38),流速为1.0 ml/min,检测波长为255nm,柱温30℃;结果:羟苯甲酯的浓度在2.0271~253.3824μg/ml范围内与色谱峰面积呈现良好的线性关系(r=0.9998),平均回收率为98.9%,RSD%=0.87%;羟苯乙酯的浓度在2.0044~250.5492μg/ml范围内与色谱峰面积呈现良好的线性关系(r=0.9999),平均回收率为99.1%,RSD%=1.01%。结论:本方法简便、快速、准确,可用于氨碘肽滴眼液中抑菌剂羟苯甲酯、羟苯乙酯的含量测定。

Objective： To establish a method for the determination of Methylparaben and Ethylparaben in Amiotide Eye Drops by HPLC. Methods： The analytical column was Agilent Eclipse XDB-C18 （150 mm × 4.6 mm,5μm）; with the column temperature of 30℃. The mobile phase as 0.005mol·L^-1 ammonium acetate solution （1000ml consisted of 10ml triethanolamine and pH was adjusted to 5.0 with glacial acetic acid）-acetonitrile （62：38）. with flow rate of 1.0 ml· min^-1. The detection wavelength was at 255nm. Result： The lin- ear ranges of methylparaben and ethylparaben at 2.0271 -253.3824μg· ml^-1 （r=-0.9998） and 2.0044-250.5492μg· ml^-1（r=0.9999） respectively. The average recoveries of methylparaben and ethylparaben was 98.9%, RSD%=0.87% and 99.1%, RSD%=1.01% respectively. Conclusion： The method is simple,accurate,it can be used for the quality control of Amiotide Eye Drops.