HPLC法同时测定小儿咳喘灵口服液中7种防腐剂的含量  

Simultaneous Determination of Seven Preservatives in Xiaoer Kechuanling Oral Liquid by HPLC

作　　者：袁媛 钟水生 张华锋 王亚琼 孙秀华 周坚 Yuan Yuan;Zhong Shuisheng;Zhang Huafeng;Wang Yaqiong;Sun Xiuhua;Zhou Jian(Suzhou Institute for Drug Control,Jiangsu Suzhou 215000,China)

机构地区：[1]苏州市药品检验检测研究中心,江苏苏州215000

出　　处：《中国药师》2020年第12期2473-2476,共4页China Pharmacist

基　　金：苏州市科技计划项目(编号:SYSD2018218)。

摘　　要：目的:建立HPLC法同时检测小儿咳喘灵口服液中苯甲酸、山梨酸、对羟基苯甲酸甲酯、对羟基苯甲酸乙酯、对羟基苯甲酸丙酯、对羟基苯甲酸丁酯、对羟基苯甲酸异丁酯等7种防腐剂的含量方法。方法:采用Agilent ZORBAX SB-phenyl(250mm×4.6 mm,5μm)色谱柱,以乙腈-0.2%磷酸溶液为流动相,梯度洗脱,流速1 ml·min-1,检测波长分别为230 nm和255 nm。结果:7种防腐剂在0.5~20μg·ml-1线性范围内均呈良好线性关系(r>0.999)。平均回收率为102.3%~103.3%,RSD 0.3%~0.4%(n=6)。检出限(LODs,S/N≥3)为0.01~0.03μg·ml-1。结论:该方法简便、准确、重复性好,可用于小儿咳喘灵口服液中防腐剂限量的测定。Objective: To establish an HPLC method for the simultaneous determination of benzoic acid,sorbic acid,methyl phydroxybenzoate,ethyl p-hydroxybenzoate,propyl p-hydroxybenzoate,butyl p-hydroxybenzoate and isobutyl p-hydroxybenzoate in Xiaoer Kechuanling oral liquid. Methods: The chromatographic separation was performed on an Agilent ZORBAX SB-phenyl( 250 mm ×4.6 mm,5 μm) column with acetonitrile-0.2% phosphoric acid solution as the mobile phase( gradient elution). The flow rate was 1 ml·min-1 and the detection wavelengths were 230 nm and 255 nm. Results: Good linear relationships of 7 preservatives were found within the range of 0.5-20 μg·ml-1( r>0.999). The average recovery was 96.7%-97.7% and the RSD was 0.3%-0.4%. The limits of detection( LODs,S/N≥3) ranged from 0.01 to 0.03 μg·ml-1. Conclusion: The method is simple,accurate and reproducible,and can be used for the determination of preservatives in Xiaoer Kechuanling oral liquid.

关 键 词：小儿咳喘灵口服液 防腐剂 苯甲酸 山梨酸 羟苯酯类 

分 类 号：R927.1[医药卫生—药学]