HPLC法测定吡诺克辛钠滴眼液中羟苯甲酯、羟苯丙酯的含量

Determination of Methylparaben and Propylparaben in Pirenoxine Sodium Eye Drops by HPLC

目的:建立吡诺克辛钠滴眼液中抑菌剂羟苯甲酯、羟苯丙酯高效液相色谱法测定的方法。方法:色谱柱:Agilent SB-C_(18)(150 mm×4.6 mm,5μm);流动相:0.01mol/L乙酸铵溶液(称取乙酸铵0.76g,加水溶解并稀释至1000ml,加15ml三乙胺,用冰醋酸调节pH值至4.5)-乙腈(60:40),流速为1.0 ml/min,检测波长为256nm,柱温30℃;结果:羟苯甲酯的浓度在2.0432~255.4000μg/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100.1%,RSD%=0.95%;羟苯丙酯的浓度在2.1400~267.5000μg/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99.0%,RSD%=0.99%。结论:本方法简便、快速、准确,可用于吡诺克辛钠滴眼液中抑菌剂羟苯甲酯、羟苯丙酯的含量测定。

Objective:To establish a method for the determination of Methylparaben and Ethylparaben in Amiotide Eye Drops by HPLC. Methods:The analytical column was Agilent SB-C_(18)(150 mm×4.6 mm,5μm);with the column temperature of 30℃. The mobile phase as 0.01 mol·L^(-1) ammonium acetate solution( 1000 ml consisted of 15 ml triethanolamine and p H was adjusted to 4.5 with glaciao acetic acid)-acetonitrile(60:40). with flow rate of 1.0 ml/min. The detection wavelength was at 256 nm. Result:The linear ranges of methylparaben, and ethylparaben at 2.0432~255.4000μg·ml(r=0.9999) and 2.1400~267.5000μg·ml(r=0.9999) respectively.The average recoveries of methylparaben, and ethylparaben was 100.1%,RSD%=0.95% and 99.0%,RSD%=0.99%respectively. Conclusion:The method is simple,accurate,it can be used for the quality control of Amiotide Eye Drops.