液相色谱法测定口服中成药制剂中防腐剂含量

Determination of Preservative Content in Oral Chinese Patent Medicine Preparation by HPLC

目的 :寻找防腐剂在药物中的简单、快速、准确的检测方法 ;方法 :用梯度洗脱液相色谱法测定口服中成药制剂中防腐剂含量。结果 :此法能同时检测 5种常用的防腐剂 :山梨酸、苯甲酸、水杨酸、对羟基苯甲酸的甲酯和乙酯。应用此法对 10 9个不同口服液样本进行检测 ,发现有接近 80 %的样本含有防腐剂。结论 :实验证明此法准确性、重复性均良好。

Objective: To seek a simple, quick and accurate determination method of preservatives in drug.Methods: A HPLC method with gradient elution was introduced for the determination of preservatives in oral Chinese patent medicine preparation. Results: This method can simultaneously determine 5 commonly used preservatives, including sorbic acid, benzoic acid, salicylic acid, emthyl and ethyl esters of methyl parabenzoic acid.Conclusion: This method shows good accuracy and reproducibility. The method was applied to the examination of 109 oral liquid samples, about 80% of them were found to contain the preservatives.