离子色谱法测定滴眼剂中抑菌剂苯扎氯铵和苯扎溴铵  

Determination of Benzalkonium Chloride and Benzalkonium Bromide in Eye Drops by Ion Chromatography

作　　者：夏方亮 顾晶晶 曹洪杰 王建强 雷永艳 崔玉婧 XIA Fang-liang;GU Jing-jing;CAO Hong-jie;WANG Jian-qiang;LEI Yong-yan;CUI Yu-jing(Binzhou Inspection and Testing Center,Binzhou 256600,China;Binzhou Key Laboratory of Chemical Drug R&D and Quality Control in Preparation,Binzhou 256600,China)

机构地区：[1]滨州市检验检测中心,山东滨州256600 [2]滨州市化学药物研发与质量控制重点实验室(筹),山东滨州256600

出　　处：《食品与药品》2024年第1期30-33,共4页Food and Drug

基　　金：滨州市农社领域科技创新政策引导计划项目(编号:2022SHFZ043)。

摘　　要：目的采用离子色谱法测定滴眼剂中抑菌剂苯扎氯铵和苯扎溴铵的含量。方法采用SH-AC-11色谱柱(250 mm×4.6 mm),电导检测器,淋洗液为23 mmol/L氢氧化钾溶液,流速为0.6 ml/min,抑制器电流为56 mA,进样量为25μl。结果苯扎氯铵和苯扎溴铵分别在1.25~62.50μg/ml和1.02~51.00μg/ml范围内线性关系良好(r分别为0.9997和0.9998),加样回收率分别为100.6%(RSD=1.7%)和100.4%(RSD=1.6%)。结论该方法准确性高,专属性强,可用于滴眼剂中抑菌剂苯扎氯铵和苯扎溴铵的质量控制。Objective To determine the contents of benzalkonium chloride and benzalkonium bromide as bacteriostatic agents in eye drops by ion chromatography.Methods The assay was performed on SH-AC-11 column(250 mm×4 mm)by conductivity detector,the eluent was 23 mmol/L potassium hydroxide solution with the flow rate of 0.6 ml/min,the suppressor current was 56 mA,and the sample injection volume was 25μl.Results Benzalkonium chloride presented a good linearity between peak area and concentration in the range of 1.25-62.50μg/ml(r=0.9997)with the average recovery of 100.6%(RSD=1.7%),and benzalkonium bromide presented a good linearity in the range of 1.02-51.00μg/ml(r=0.9998)with the average recovery of 100.4%(RSD=1.6%).Conclusion This method has high accuracy and strong specificity,and can be used for the quality control of benzalkonium chloride and benzalkonium bromide in eye drops.

关 键 词：滴眼剂 抑菌剂 离子色谱 苯扎氯铵 苯扎溴铵 质量控制 

分 类 号：R927[医药卫生—药学]