HPLC法同时测定通脉口服液中9种甜味剂和防腐剂的研究  

Simultaneous Determination of Nine Sweeteners and Preservatives in Tongmai Oral Liquid by HPLC

作　　者：周凌 姜范成 李宪刚 高珊 胡景莲 ZHOU Ling;JIANG Fan-cheng;LI Xian-gang;GAO Shan;HU Jing-lian(Dalian Inspection and Testing Certification Technical Service Center,Liaoning Dalian 116021,China)

机构地区：[1]大连市检验检测认证技术服务中心,辽宁大连116021

出　　处：《中国药物评价》2019年第1期37-40,共4页Chinese Journal of Drug Evaluation

摘　　要：目的:建立通脉口服液中苯甲酸、山梨酸钾、安赛蜜、糖精钠、阿斯巴甜、对羟基苯甲酸酯类等9种甜味剂及防腐剂的高效液相测定方法,为有效控制成方制剂的安全性提供参考。方法:采用高效液相色谱法,二极管阵列检测器,色谱柱为Thermo HYPERSIL GOLD Aq C18(4.6 mm×150 mm,5μm),流动相为乙腈和0.02 mol·L-1磷酸二氢铵(用三乙胺调pH值为5.5)梯度洗脱。结果:9种成分线性关系良好,均在线性范围内,10批通脉口服液样品中的山梨酸钾含量均在可控范围内。结论:该方法专属性强,简单易行,适用于通脉口服液中9种甜味剂和防腐剂的测定。Objective:To establish a method for the determination of 9 sweeteners and preservatives in Tongmai oral liquid,such as benzoic acid,potassium sorbate,acesulfame,saccharin sodium,aspartame and p-hydroxybenzoate,by high performance liquid chromatography(HPLC),and to provide reference for the effective control of the safety of prescription preparations.Methods:HPLC with diode array detector and Thermo HYPERSIL GOLD Aq C 18(4.6 mm×150 mm,5μm)was used.The mobile phase was acetonitrile and 0.02 mol·L^-1 ammonium dihydrogen phosphate(adjusted by triethylamine to pH value by 5.5)gradient elution.Results:The linearity of the nine components was good,and the content of potassium sorbate in 10 batches of Tongmai oral liquid samples was within the controllable range.Conclusion:The method is simple and specific,and suitable for the determination of 9 sweeteners and preservatives in Tongmai oral liquid.

关 键 词：高相液相色谱法 山梨酸钾 通脉口服液 

分 类 号：R927.2[医药卫生—药学]