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《化学分析计量》 2020年第03期
DOI:10.3969/j.issn.1008-6145.2020.03.016
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
黄祝刚,李亚囡,孙滨滨,贾佳,唐彬,郑琪欣
山东齐都药业有限公司,山东淄博 255400 
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
Shandong Qidu Pharmaceutical Co., Ltd., Zibo 255400, China 
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×320 μm,0.5 μm)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 0.055,0.019,0.023,0.070,0.155,0.013,0.003,0.009,0.004,0.004,0.004,0.005 μg/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。 
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×320 μm, 0.5 μm) 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, 0.005 μg/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. 
关键词:顶空-气相色谱法;葡萄糖氯化钠注射液;残留溶剂 
Keywords:headspace-gas chromatography; glucose and sodium chloride injection; residual solvents 
本文引用格式:
黄祝刚,李亚囡,孙滨滨,等.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.
HUANG Z G,LI Y N,SUN B B,et al. Determination of 12 solvents residues in glucose sodium chloride injection by headspace-gas chromatography[J]. Chemical analysis and meterage,2020,29(3):68-71. 

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