HPLC法测定不同厂家小儿止咳糖浆中防腐剂的含量  

Determination of Preservative Contents in Xiaoer Zhike Syrups by HPLC

作　　者：时佩 冯有龙 鲁寅生 黄萍 SHI Pei;FENG Youlong;LU Yinsheng;HUANG Ping(College of Pharmacy,Nanjing University of Chinese Medicine,Nanjing 210023,China;Jiangsu Institute for Food and Drug Control,Nanjing 210019,China)

机构地区：[1]南京中医药大学药学院,南京210023 [2]江苏省食品药品监督检验研究院,南京210019

出　　处：《药学与临床研究》2022年第4期323-326,共4页Pharmaceutical and Clinical Research

基　　金：2021年国家药品计划抽验品种。

摘　　要：目的:针对小儿止咳糖浆中的苯甲酸等6种防腐剂建立了HPLC含量测定方法。方法:采用Agilent ZORBAX SB-Aq(250 mm×4.6 mm,5μm)色谱柱;以甲醇-0.02 mol·L^(-1)醋酸铵溶液(pH 3.00)为流动相,梯度洗脱;柱温40℃;检测波长为苯甲酸232 nm,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255 nm。结果:上述6种防腐剂浓度依次在10.16~203.28、10.17~203.48、10.28~205.64、10.37~207.32、10.34~206.88、10.31~206.28μg·mL^(-1)范围内与各自峰面积呈良好的线性关系(r≥0.9998)。该方法精密度、重复性、稳定性的RSD均<2%(n=6);6种防腐剂的平均加样回收率范围为98.30%~101.5%,RSD均<1%(n=6)。结论:该方法操作简便,专属性强,准确度高,为小儿止咳糖浆中防腐剂的含量控制提供依据。Objective:To determine the contents of six preservatives in Xiaoer Zhike syrups by HPLC.Methods:An Agilent ZORBAX SB-Aq column(250 mm×4.6 mm,5μm)was used as the solid phase;the mobile phase was methanol-0.02 mol·L^(-1) ammonium acetate solution(adjusted to pH 3.00 with glacial acetic acid)for gradient elution;the column temperature was 40℃;the detection wavelength was 232 nm for benzoic acid,and 255 nm for sorbic acid,methyl p-hydroxybenzoate,ethyl p-hydroxybenzoate,propyl p-hydroxybenzoate and butyl p-hydroxybenzoate.Results:The linear ranges of the six preservatives were 10.16-203.28,10.17-203.48,10.28-205.64,10.37-207.32,10.34-206.88 and 10.31-206.28μg·mL^(-1),respectively(all r≥0.9998).RSDs of precision,repeatability and stability tests were all less than 2%(n=6);average recoveries of the six preservatives ranged from 98.30%to 101.46%,and the RSDs were less than 1%(n=6).Conclusion:The method is simple,exclusive and accurate.It can be used for content control of preservatives in Xiaoer Zhike syrups.

关 键 词：HPLC法 小儿止咳糖浆 防腐剂 含量测定 苯甲酸 

分 类 号：R927.2[医药卫生—药学]