| 卢玉凤,李洁,梅芊.GC-MS法测定硫酸庆大霉素滴眼液中17种邻苯二甲酸酯类[J].中国药事,2022,36(7):818-825 |
| GC-MS法测定硫酸庆大霉素滴眼液中17种邻苯二甲酸酯类 |
| Determination of 17 Kinds of Phthalates in Gentamicin Sulfate Eye Drops by GC-MS |
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| DOI：10.16153/j.1002-7777.2022.07.011 |
| 中文关键词: 气相色谱-质谱联用法 17种邻苯二甲酸酯类 硫酸庆大霉素滴眼液 原辅料 包材 |
| 英文关键词: GC-MS 17 kinds of phthalates gentamicin sulfate eye drops raw and auxiliary materials packaging materials |
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| 中文摘要: |
| 目的：建立硫酸庆大霉素滴眼液中17种邻苯二甲酸酯类增塑剂残留量的GC-MS测定方法。方法：采用Agilent HP-5MS气相色谱柱(30 m×0.25 mm，0.25 μm)，载气为高纯度氦气(He)，进样口温度为260 ℃，脉冲不分流进样，程序升温，进样量为1 μL，离子源为电子轰击源(EI)，电离电压为70 eV，离子源温度为300 ℃，质谱传输接口温度为280 ℃，四级杆温度为180 ℃，质谱监测模式为选择离子(SIM)模式，外标法定量。结果：17种邻苯二甲酸酯类增塑剂均在相应的浓度范围内线性关系良好，方法精密度、重复性、回收率、稳定性均符合相关规定。原辅料中检出4种邻苯二甲酸酯类增塑剂，包材中检出6种邻苯二甲酸酯类增塑剂，硫酸庆大霉素滴眼液中检出6种邻苯二甲酸酯类增塑剂。结论：所建立的方法灵敏度高、准确性高、重复性好、速度快，同时提取方法简单，可用于硫酸庆大霉素滴眼液中17种邻苯二甲酸酯类增塑剂迁移情况的监测和溯源。 |
| 英文摘要: |
| Objective: To establish a GC-MS method for determining the content of 17 kinds of phthalate plasticizer residues in gentamicin sulfate eye drops. Methods: GC-MS was performed on Agilent HP-5MS column (30 m×0.25 mm, 0.25 μm) by using high purity He as carrier gas. The injector temperature was 260 ℃ by using pulse splitless injection technique under temperature rising program. The sample volume was 1 μL. The ion source temperature was 300 ℃, the ionization energy was 70 eV, the temperature of MS transmission interface was 280 ℃ and the MS quard temperature was 180 ℃. The mass spectrometry monitoring mode was SIM, which was quantifi ed by external reference method. Results: The 17 kinds of phthalate ester plasticizers showed good linear relationship in the corresponding concentration range. The precision, repeatability, recovery and stability of the method were all in line with the relevant provisions. Four phthalate plasticizers were detected in raw auxiliary materials, six phthalate plasticizers were detected in packaging materials, and six phthalate plasticizers were detected in gentamicin sulfate eye drops. Coclusion: The established method has the advantages of high sensitivity, high accuracy, good repeatability, fast speed and the extraction method is simple, therefore it can be used to monitor and trace the migration of 17 kinds of phthalate plasticizers in gentamicin sulfate eye drops. |
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