文章摘要
付蒙,陈晓莉,周姝,江燕.顶空气相色谱-质谱法测定药品包装材料中40种有机溶剂残留量[J].中国药品标准,2023,24(1):
顶空气相色谱-质谱法测定药品包装材料中40种有机溶剂残留量
Simultaneous determination of 40 kinds of organic solvent residues in pharmaceutical package by headspace GC-MS method
投稿时间:2022-07-11  修订日期:2023-02-01
DOI:
中文关键词: 顶空气相色谱-质谱法  药品包装材料  药用复合膜  药用铝箔  药用复合硬片  有机溶剂  残留量
英文关键词: Head-space GC-MS  Pharmaceutical packaging materials  Laminated film  Aluminium foil  Composite sheet  Organic solvent  Residues
基金项目:
作者单位E-mail
付蒙 湖北省药品监督检验研究院 397262414@qq.com 
陈晓莉 湖北省药品监督检验研究院  
周姝 湖北省药品监督检验研究院  
江燕* 湖北省药品监督检验研究院 397262414@qq.com 
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中文摘要:
      目的:建立测定药品包装材料中正辛烷、丙酮、辛烯、乙酸乙酯等40种有机溶剂残留量的方法。方法:采用顶空气相色谱-质谱法,色谱条件为Agilent VF-WAX MS毛细管气相色谱柱(60 m × 0.32 mm,1.00 μm),柱温为程序升温(起始温度45 ℃,保持5 min,以5 ℃·min-1升温至150 ℃,再以20 ℃·min-1升温至220 ℃,保持4 min),进样口温度:220℃;载气为高纯氦气,流速为1.0 mL·min-1,分流比为10:1;进样体积为1 mL;质谱条件为电子轰击离子源(EI),轰击电压70 ev;离子源温度为280 ℃,接口温度250 ℃;扫描方式:定性SCAN(质量数范围29 ~ 650),定量SIM。结果:所建立的方法呈良好的线性关系,相关系数r为0.9953 ~ 0.9996,各有机溶剂平均回收率均在94.25 % ~ 107.46 %范围内,RSD为0.06 % ~ 1.92 %。
英文摘要:
      Objective: To establish a method for the determination of 40 organic solvents such as n-octane, acetone, octene and ethyl acetate residues in drug packaging materials. Methods: Headspace gas chromatography-mass spectrometry was performed on an Agilent VF-WAX MS capillary gas chromatography-mass spectrometry column (60 m × 0.32 mm, 1.00 μm). The column temperature was programmed temperature(The initial temperature was 45 ℃ for 5 min, and the temperature was increased to 150 ℃ at 5 ℃·min-1. The temperature was increased to 220 ℃ at 20 ℃·min-1 for 4 min), and the inlet temperature was 220 ℃. The carrier gas was high-purity helium gas with a flow rate of 1.0 mL·min-1 and a split ratio of 10:1. The injection volume was 1 mL. The mass spectrometric conditions were as follows: electron bombarding ion source (EI), bombarding voltage 70 eV; Ion source temperature was 280 ℃, interface temperature was 250 ℃; Scanning mode: Qualitative SCAN(m/z 29 ~ 650), quantitative SIM. Results: The correlation coefficient r was 0.9953 ~ 0.9996. The average recoveries of all organic solvents were in the range of 94.25 % ~ 107.46 %, and RSD was 0.06 % ~ 1.92 %. Conclusion: The results showed that the method was suitable for the determination of organic solvent residues in pharmaceutical packaging materials including laminated film, aluminium foil and composite sheet.
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