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作 者:方琳美 胡咪[1] 陈爱连[1] 徐雪萍[1] 施超欧[1] FANG Lin-mei HU Mi CHEN Ai-lian XU Xue-ping SHI Chao-ou(Analysis and Research Center East China University of Science and Technology, Shanghai 200237. Chin)
出 处:《药物分析杂志》2016年第10期1852-1856,共5页Chinese Journal of Pharmaceutical Analysis
摘 要:目的:利用离子色谱法建立盐酸阿比朵尔中残留二甲胺的含量测定方法。方法:采用阳离子交换柱[Dionex Ion Pac CG16(5 mm×50 mm)+C S16(5 mm×250 mm)],以30 mmol·L^(-1)甲基磺酸为淋洗液,流速1.0 m L·min^(-1),柱温30℃,电导检测器检测,抑制器为CSRS 300(4 mm)。结果:二甲胺质量浓度在0.031~4.0 mg·L^(-1)范围内线性关系良好(r=0.999 9),二甲胺对照品溶液(1 mg·L^(-1))连续6次进样,保留时间、峰高、峰面积的RSD都小于1.5%,本检测方法的检出限为0.001 mg·L^(-1),定量限为0.004 mg·L^(-1),样品的日内和日间RSD分别为1.7%和2.8%,3个水平的加标提取回收率在94.7%~105.0%之间,3个批次样品中残留二甲胺的含量分别为0.021 2%、0.023 1%、0.020 7%。结论:本方法经方法学验证,可有效监控盐酸阿比朵尔的质量。Objective:To establish a determination method for the residual dimethylamine in arbidol hydrochloride by ion chromatography. Methods: The determination was carried on a cation exchange column [Dionex Ion Pac CG16(5 mm×50 mm)+CS16(5 mm×250 mm)] with 30 mmol·L-1methanesulfonic acid solution as eluent by electrical conductivity detector. The flow rate was 1.0 m L·min-1,the column temperature was 30 ℃,and the suppressor was CSRS 300(4 mm). Results: There was a good linearity over the range of 0.031-4.0 mg·L-1 with the correlation coefficient higher than 0.999 9. With 6 consecutive samples of dimethylamine reference substance solution(1 mg·L-1),the RSD of retention time,peak height and peak area were all below 1.5%. The detection limit of the method was 0.001 mg·L-1,and the quantitative limit was 0.004 mg·L-1. Intra-day and inter-day RSDs of samples were 1.7% and 2.8%. Three levels of spiked recovery were between 94.7% and 105.0%. The content of the residual dimethylamine in three batches of samples were 0.021 2%,0.023 1%,and 0.020 7%,respectively.Conclusion:The method is proved by methodology validation that it can be effectively used in quality control of arbidol hydrochloride.
关 键 词:抗病毒药 盐酸阿比朵尔 二甲胺残留 杂质检测 安全监测 离子色谱
分 类 号:R917[医药卫生—药物分析学]
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