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气相色谱法测定盐酸阿比多尔中6种残留溶剂
引用本文:杨明欣.气相色谱法测定盐酸阿比多尔中6种残留溶剂[J].中国药品标准,2021,22(2):159-163.
作者姓名:杨明欣
作者单位:山东省莒县中医医院
摘    要:目的:建立气相色谱法(GC)测定盐酸阿比多尔中的丙酮、甲醇、乙醇、异丙醇、二氯甲烷和三氯甲烷6种有机溶剂残留量。方法:采用Thermo WAX气相色谱柱(30 m×0.25 mm,0.25μm);FID检测器;进样口温度为220℃,检测器温度为240℃;载气为氮气,载气流速为2 mL·min-1;采用程序升温法:起始温度为40℃,保持10 min,以40℃·min-1的速率升温至200℃,保持5 min。结果:6种残留溶剂在各自浓度范围内线性关系良好(r>0.999);平均回收率为95.91%~102.29%,RSD为1.90%~3.67%。结论:本法操作简单、准确度高、重现性好,可用于盐酸阿比多尔原料药中6种有机溶剂残留量的测定。

关 键 词:残留溶剂  气相色谱法  盐酸阿比多尔

Determination of six residual solvents in arbidol hydrochloride by GC
Authors:YANG Mingxin
Institution:(Juxian TCM Hospital,Juxian Shandong 276500,China)
Abstract:Objective:To establish a GC method for simultaneous determination of the six residual solvents of acetone,methanol,ethanol,isopropanol,dichloromethane and trichloromethane in arbidol hydrochloride.Methods:The determination was performed in Thermo WAX capillary column(30 m×0.25 mm,0.25μm)under the programmed temperature.FID was used,the inlet temperature was 220℃and the detector temperature was 240℃.The nitrogen was as the carrier gas and the flow rate of carrier gas was 2 mL·min-1.The column temperature program was set as:remaining the starting temperature of 40℃for 10 min,then increasing to 200℃at the rate of 40℃·min-1 and remaining 200℃for 5 min.Results:Six residual solvents had a good linearity in the respective concentration ranges(r>0.999).The average recoveries were 95.91%-102.29%with RSDs as 1.90%-3.67%.Conclusion:The established method is simple,accurate and reproducible.It can be used for determination of six residual solvents in arbidol hydrochloride.
Keywords:residual solvents  GC method  arbidol hydrochloride
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