HPLC法测定盐酸氨溴索口服液体制剂中防腐剂含量  

HPLC determination of preservative contents in ambroxol hydrochloride oral liquid preparations

作　　者：江文明[1] 金薇[1] 宋冬梅[1] 杨永健[1] 

机构地区：[1]上海市食品药品检验所,上海201203

出　　处：《药物分析杂志》2012年第10期1838-1841,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立超高效液相色谱-多波长检测法同时测定盐酸氨溴索口服溶液及糖浆中9种防腐剂。方法:色谱柱:AgilentZorbax Eclipse XDB C18色谱柱(50 mm×4.6 mm,1.8μm),流动相:乙腈-磷酸盐缓冲溶液,梯度洗脱,流速:1.5 mL·min-1,柱温:40℃。定量波长为各组分的最大吸收波长。通过改变磷酸盐缓冲液的pH,排除了样品中氨溴索主峰对测定的干扰。结果:9种防腐剂分离完全,峰形良好。在2～100μg·mL-1的浓度范围内线性关系良好(r≥0.999),精密度RSD<2.0%,平均加样回收率为98%～102%。结论:该方法简单快速,分离效果好,可用于盐酸氨溴索口服液体制剂中防腐剂的筛查和定量测定。Objective：To establish a high performance liquid chromatography-diode array detection（HPLC-DAD） method to simultaneously determine nine kinds of preservatives in ambroxol hydrochloride oral solution and syrup.Methods：The method was conducted on an Agilent ZORBAX Eclipse XDB C18 column（50 mm×4.6 mm,1.8 μm） with phosphate buffered solution and acetonitrile as mobile phase,by gradient elution at a flow rate of 1.5 mL·min-1.The column temperature was set at 40 ℃.The interference of impurity peaks was eliminated by adjusting the pH of buffer solution in the mobile phase.The quantitative wavelength was the maximum absorption wavelength of each component.Results：Complete separation of nine kinds of preservatives was achieved with fine peak shapes.The calibration curves were linear in the range of 2-100 μg·mL-1（r≥0.999）.The average recoveries were between 98% and 102%,and the RSD was less than 2%.Conclusion：The method was convenient,rapid,with good separation,which can be used for screen and quantitatively determination of preservatives in ambroxol hydrochloride oral liquid preparations.

关 键 词：高效液相色谱 盐酸氨溴索 口服溶液 糖浆制剂 防腐剂含量测定 苯甲醇 苯甲酸 山梨酸 苯氧乙醇 苯乙醇 对羟基苯甲醇甲酯 对羟基苯甲酸乙酯 对羟基苯甲酸丙酯 对羟基苯甲酸丁酯 

分 类 号：R917[医药卫生—药物分析学]