| 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 |
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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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