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顶空-气相色谱法测定葡萄糖氯化钠注射液中12种溶剂残留量
引用本文:黄祝刚,李亚囡,孙滨滨,贾佳,唐彬,郑琪欣. 顶空-气相色谱法测定葡萄糖氯化钠注射液中12种溶剂残留量[J]. 化学分析计量, 2020, 29(3): 68-71. DOI: 10.3969/j.issn.1008-6145.2020.03.016
作者姓名:黄祝刚  李亚囡  孙滨滨  贾佳  唐彬  郑琪欣
作者单位:山东齐都药业有限公司,山东淄博 255400;山东齐都药业有限公司,山东淄博 255400;山东齐都药业有限公司,山东淄博 255400;山东齐都药业有限公司,山东淄博 255400;山东齐都药业有限公司,山东淄博 255400;山东齐都药业有限公司,山东淄博 255400
摘    要:建立顶空-气相色谱法测定葡萄糖氯化钠注射液中12种残留溶剂含量的方法。采用HP-INNOWAX毛细管色谱柱(60 m×320μm,0.5μm)为分离柱,检测器为氢火焰离子化检测器(FID),柱温为程序升温。12种残留溶剂乙醇、异丙醇、丙酮、丁酮、乙酸乙酯、乙酸丁酯、乙酸正丙酯、甲苯、乙苯、对二甲苯、邻二甲苯、间二甲苯均能完全分离,在考察的浓度范围内线性关系良好(r>0.995),检出限分别为0.055,0.019,0.023,0.070,0.155,0.013,0.003,0.009,0.004,0.004,0.004,0.005μg/mL。平均回收率为90.6%~109.0%,测定结果的相对标准偏差为2.2%~5.6%(n=9)。该方法专属性强,精密度、准确度和检测灵敏度高,重复性好,可用于葡萄糖氯化钠注射液中12种溶剂残留量的测定。

关 键 词:顶空-气相色谱法  葡萄糖氯化钠注射液  残留溶剂

Determination of 12 solvents residues in glucose sodium chloride injection by headspace-gas chromatography
HUANG Zhugang,LI Yanan,SUN Binbin,JIA Jia,TANG Bin,ZHENG Qixin. Determination of 12 solvents residues in glucose sodium chloride injection by headspace-gas chromatography[J]. Chemical Analysis And Meterage, 2020, 29(3): 68-71. DOI: 10.3969/j.issn.1008-6145.2020.03.016
Authors:HUANG Zhugang  LI Yanan  SUN Binbin  JIA Jia  TANG Bin  ZHENG Qixin
Affiliation:(Shandong Qidu Pharmaceutical Co.,Ltd.,Zibo 255400,China)
Abstract:The method for the determination of 12 residual solvents in glucose and sodium chloride injection by headspace-gas chromatography was developed.HP-INNOWAX capillary column(60 m×320μm,0.5μm)and hydrogen flame ionization detector(FID)were used for determination by programmed temperature rise.The 12 kinds of residual solvents(ethanol,isopropanol,acetone,butanone,ethyl acetate,butyl acetate,normal propyl acetate,toluene,ethyl benzene and p-xylene,o-xylene,m-xylene)were completely separated,and the linear relationship was good within the concentration range(r>0.995),and the detection limits were 0.055,0.019,0.023,0.070,0.155,0.013,0.003,0.009,0.004,0.004,0.004,0.005μg/mL,respectively.The recovery was 90.6%-109.0%,and the relative standard deviation was 2.2%-5.6%(n=9).The method has strong specificity with high precision,accuracy,detection sensitivity and good repeatability,which can be used for the determination of 12 residual solvent residues in glucose and sodium chloride injection.
Keywords:headspace-gas chromatography  glucose and sodium chloride injection  residual solvents
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