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超高效液相色谱法测定药用复合膜中7种水溶性荧光增白剂
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作者单位
左军凤,贺针华,熊马剑,朱碧君 1.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2.江西中医药大学 
基金项目:江西省重点研发计划项目(20192BBGL70047)
中文摘要:建立了一种同时测定药用复合膜中7种水溶性荧光增白剂的超高效液相色谱(UPLC)分析方法。样品经40%乙腈水溶液(三乙胺调至pH 11.0)提取。采用 Waters ACQUITY UPLC BEH C18色谱柱(100 mm×2.1 mm,1.7 μm)进行分离,以乙腈-甲醇混合溶液(2∶3)和含10 mmol/L四丁基溴化铵的甲醇-水溶液(5∶95)为流动相,调至pH 8.0后进行梯度洗脱,流速为0.2 mL/min,检测波长为350 nm,柱温为40 ℃。结果表明,7种水溶性荧光增白剂在相应的质量浓度范围内线性关系良好,相关系数(r)为0.998 6~0.999 7,方法检出限为0.17~1.29 μg/mL,定量下限为0.55~3.85 μg/mL,3个加标水平的平均回收率为83.2%~110%,相对标准偏差(RSD)为4.0%~9.7%。样品测定结果显示,聚酯/铝/聚乙烯药用复合膜和纸/铝/聚乙烯药用复合膜最多检出两种荧光增白剂,其他品种样品均未检出荧光增白剂。该方法操作简便、可靠、重复性好,可用于药用复合膜中水溶性荧光增白剂的测定。
中文关键词:超高效液相色谱法(UPLC)  药用复合膜  水溶性  荧光增白剂
 
Determination of 7 Water soluble Fluorescent Whitening Agents in Medicinal Composite Films by Ultra-high Performance Liquid Chromatography
Abstract:An ultra high performance liquid chromatographic(UPLC) method was developed for the simultaneous determination of seven water soluble fluorescent whitening agents in medicinal composite films.The sample was extracted with 40% acetonitrile aqueous solution adjusted to pH 11.0 with triethylamine,and separated on a Waters ACQUITY UPLC BEH C18(100 mm×2.1 mm,1.7 μm) at 40 ℃ by gradient elution with acetonitrile-methanol solution(2∶3) and 10 mmol/L tetrabutylammonium bromide-methanol solution(5∶95,pH 8.0) as mobile phases at a flow rate of 0.2 mL/min.The detection wavelength was set at 350 nm.Results showed that there were good linear relationships for the analytes in corresponding concentration ranges with their correlation coefficients(r) of 0.998 6-0.999 7.The limits of detection(LOD) and limits of quantitation(LOQ) of the method were in the ranges of 0.17-1.29 μg/mL and 0.55-3.85 μg/mL,respectively.The average recoveries at three spiked levels ranged from 83.2% to 110%,with relative standard deviations(RSD) of 4.0%-9.7%.The detection results showed that two kinds of fluorescent whitening agents were detected in the polyester/aluminum/polyethylene medicinal composite film and paper/aluminum/polyethylene medicinal composite films at most,no fluorescent whitening agent was detected in other varieties.The method is simple,reliable and repeatable,and could be used for the determination of fluorescent whitening agents in medicinal composite films.
Key Words:ultra high performance liquid chromatography(UPLC)  medicinal composite films  water soluble  fluorescent whitening agents
引用本文:左军凤,贺针华,熊马剑,朱碧君.超高效液相色谱法测定药用复合膜中7种水溶性荧光增白剂[J].分析测试学报,2020,39(9):1098-1104.
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