高效液相色谱法检测药用复合膜中荧光增白剂  

Determination of fluorescent whitening agents in medicinal composite films by high performance liquid chromatography

作　　者：贺针华 左军凤 熊马剑 朱碧君 HE Zhen-hua;ZUO Jun-feng;XIONG Ma-jian;ZHU Bi-jun(Jiangxi University of Traditional Chinese Medicine,Nanchang 330004,China;Jiangxi Institute for Drug Control,Jiangxi Provincial Engineering Research Center for Drug and Medical Device Quality,NMPA Key Laboratory for Quality Evaluation of Traditional Chinese Medicine,Nanchang 330029,China)

机构地区：[1]江西中医药大学,南昌330004 [2]江西省药品检验检测研究院,江西省药品与医疗器械质量工程技术研究中心,国家药品监督管理局中成药质量评价重点实验室,南昌330029

出　　处：《药物分析杂志》2020年第9期1645-1652,共8页Chinese Journal of Pharmaceutical Analysis

基　　金：江西省重点研发计划项目(20192BBGL70047)。

摘　　要：目的:建立检测药用复合膜中9种荧光增白剂的高效液相色谱分析方法。方法:样品经三氯甲烷超声提取。CAPCELL PAK C18(250 mm×4.6 mm,5μm)色谱柱,以乙腈-甲醇-水为流动相,梯度洗脱,流速为1.0 mL·min^-1,二极管阵列检测器检测。结果:9种荧光增白剂可以较好地分离,线性关系良好,相关系数(r2)均大于0.999。在低、中、高3个添加水平的回收率为96.1%~108.1%,RSD为1.1%~5.1%。结论:该方法简单,准确度和选择,可用于快速检测药用复合膜中的9种荧光增白剂。Objective:To establish a high performance liquid chromatography for the determination of nine fluorescent whitening agents in medicinal composite films.Methods:The sample was ultrasonically extracted with chloroform.CAPCELL PAK C18(250 mm×4.6 mm,5μm)was used as an analytical column with the mobile phase of acetonitrile-methanol-water by gradient elution,at the flow rate of 1.0 mL·min-1,and detection by a diode array detector.Results:The 9 kinds of fluorescent whitening agents can be separated well,the linear relationship is good,the correlation coefficient(r2)is greater than 0.999.The recoveries at low,medium and high additive levels were 96.1%-108.1%with relative standard deviation(RSD)of 1.1%-5.1%.Conclusion:The method is simple,good accurate and selective,and can be used for rapid detection of nine fluorescent whitening agents in medicinal composite films.

关 键 词：药品包装材料 药用复合膜 检测 荧光增白剂 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]