医院制剂中防腐剂羟苯乙酯的含量测定

Content Determination of Preservative Ethylparaben in Hospital Preparation

目的:建立以反相高效液相色谱法测定医院制剂中防腐剂羟苯乙酯含量的方法。方法:色谱柱为Spherisorb C18,流动相为乙腈-水(50∶50,V/V),流速为1mL.min-1,柱温为35℃,检测波长为254nm,进样量为20μL。结果:羟苯乙酯检测浓度的线性范围为1.812 5～18.125 0μg.mL-1(r=0.999 9);平均回收率为99.92%,日内RSD<2.10%,日间RSD<4.89%。结论:本方法简便、快速、准确,可用于医院制剂中防腐剂羟苯乙酯的含量测定。

OBJECTIVE： To establish a RP - HPLC method for the determination of preservative ethylparaben content in hospital preparation. METHODS： The determination was carried out on Spherisorb C18 column and the mobile phase consisted of acetonitrile - water （50 ： 50, V/V） at a flow rate of 1 mL·min^-1. The column temperature was set at 35℃ ; the detec- tion wavelength was set at 254 nm and the sample size was 20 μL. RESULTS： The linear range of ethylparaben was 1.812 5～18.125 0 μg·mL^-1 （r = 0.999 9） with an average recovery rate of 99.92%. The intra- day RSD was less than 2.10% and inter-day RSD was less than 4.89%. CONCLUSION： The method is simple, rapid and accurate, and applicable for the determination of ethylparaben content in hospital preparation.