HPLC法测定滴眼液中5种常用抑菌剂的含量  

Determination of five common bacteriostats in eye drops by HPLC

作　　者：钱保勇 朱琼 吴珺 QIAN Baoyong;ZHU Qiong;WU Jun(Taizhou Insitute for Drug Control,Taizhou 225300,China)

机构地区：[1]泰州市药品检验院,江苏泰州225300

出　　处：《中国药品标准》2023年第1期90-95,共6页Drug Standards of China

基　　金：泰州市科技支撑计划社会发展项目(项目编号SSF20190200)。

摘　　要：目的:建立HPLC法测定滴眼液中5种抑菌剂。方法:采用Waters SunFire C _(18)色谱柱(4.6 mm×250 mm,5μm),以1%三乙胺溶液(用磷酸调pH至3.0)-甲醇为流动相,梯度洗脱,流速为1.0 mL·mi^(n-1),测定波长为214 nm和262 nm。结果:5种抑菌剂可完全分离,线性关系均良好,r均大于0.999,重复性、精密度、稳定性RSD值均小于1%,回收率为98%~105%,RSD为1.2%~4.2%。对19批次滴眼液的考察,大多数标示了抑菌剂种类和浓度的滴眼液,测定结果与标示量一致。结论:本方法能同时测定常用5种抑菌剂的含量,可为滴眼液中抑菌剂的质量控制提供参考。Objective:To establish a method for the determination of five bacteriostats in eye drops by HPLC.Methods:A Waters SunFire C _(18) column(4.6 mm×250 mm,5μm)was used with gradient elution of 1%triethylamine solution(pH adjusted to 3.0 with phosphoric acid)-methanol as mobile phase at a flow rate of 1.0mL·min^(-1).The determination wavelengths were set at 214nm and 262 nm.Results:The five bacteriostatic agents could be completely separated with good linear relationship,r>0.999,RSD values of reproducibility,precision and stability were less than 1%,recovery rates were 98%-105%,RSD were 1.2%-4.2%.Most of the 19 batches of eye drops were labeled with bacteriostatic agent type and concentration,and the measured results were consistent with the labeled amount.Through the investigation of 19 batches of eye drops,most of the eye drops labeled with anti-microbial type and concentration,the determination results were consistent with the labeled amount.Conclusions:This method can simultaneously determine the contents of five commonly used bacteriostatic agents,which can provide reference for the quality control of bacteriostatic agents in eye drops.

关 键 词：滴眼液 抑菌剂 梯度洗脱 高效液相色谱法 含量测定 

分 类 号：R921.2[医药卫生—药学]