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HPLC法同时测定通脉口服液中9种甜味剂和防腐剂的研究

周凌,姜范成,李宪刚,高珊,胡景莲   

  1. 大连市检验检测认证技术服务中心,大连市检验检测认证技术服务中心,大连市检验检测认证技术服务中心,大连市检验检测认证技术服务中心,大连市检验检测认证技术服务中心
  • 收稿日期:2019-01-20 修回日期:2019-02-18 出版日期:2019-02-25 发布日期:2019-02-25

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

ZHOU Ling,,, and   

  1. Dalian Inspection and Testing Certification Technical Service Center,Dalian Inspection and Testing Certification Technical Service Center,,Dalian Inspection and Testing Certification Technical Service Center,Dalian Inspection and Testing Certification Tec
  • Received:2019-01-20 Revised:2019-02-18 Online:2019-02-25 Published:2019-02-25

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,5 μm),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。

Abstract: 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 C18 (4.6 mm×150 mm, 5 μm) 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.