| 高巧月,唐海磊,郭昕,刘正宇,何东升,涂家生.气相色谱法测定聚乙二醇单甲醚中2-甲氧基乙醇的残留量[J].中国药品标准,2023,24(2): |
| 气相色谱法测定聚乙二醇单甲醚中2-甲氧基乙醇的残留量 |
| Determination of 2-methoxyethanol residues in polyethylene glycol monomethyl ether by gas chromatography |
| 投稿时间：2022-11-18 修订日期：2023-04-04 |
| DOI： |
| 中文关键词: 2-甲氧基乙醇 气相色谱法 聚乙二醇单甲醚 |
| 英文关键词: 2-methoxyethanol gas chromatography polyethylene glycol monomethyl ether. |
| 基金项目:国家药典委员会药品标准修订研究课题（No.2020Y041）；国家“重大新药创制”科技重大专项资助项目（No.2017ZX09101001-006-002） |
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| 中文摘要: |
| 目的：建立直接进样气相色谱法测定聚乙二醇单甲醚中2-甲氧基乙醇残留量的分析方法，为聚乙二醇单甲醚的质量控制提供参考依据。方法：采用Agilent DB-WAX（30 m×0.53 mm，1.0 μm）气相色谱柱，起始柱温40 ℃，保持5min，以10 ℃/min的速率升温至200 ℃，保持10min。进样口温度200 ℃，氢火焰离子化检测器温度为250 ℃。样品以水溶解，液体进样。结果：2-甲氧基乙醇在0.5～2.0 μg/mL浓度范围内线性良好（r=0.9957），平均回收率为(105.1±3.9)%（RSD=3.7%），检测限为0.3 μg/mL，定量限为0.5 μg/mL。2-甲氧基乙醇对照品水溶液在5天内稳定。结论：本方法操作简便、环保，具有良好的系统适用性、线性、稳定性、精密度和准确度，可用于聚乙二醇单甲醚中2-甲氧基乙醇残留量的测定。 |
| 英文摘要: |
| Objective: A method for the determination of residual 2-methoxyethanol in polyethylene glycol monomethyl ether by direct injection gas chromatography was established to provide a basis for the quality control of polyethylene glycol monomethyl ether. Method: In this study, an Agilent DB-WAX (30 m×0.53 mm, 1.0 μm) gas chromatography column was used with a starting column temperature of 40 °C which was held for 5 minutes, the column temperature was increased to 200 °C at a rate of 10 °C/min and kept for another 10 minutes. The inlet temperature was 200 °C and the hydrogen flame ionization detector temperature was 250 °C. The sample is dissolved in water and injected as a liquid. Result: 2-Methoxyethanol have good linearity (r=0.9957) in the concentration range of 0.5 -2.0 μg/mL, with an average recovery of (105.1±3.9)% (RSD=3.7%), a detection limit of 0.3 μg/mL, and a quantification limit of 0.5 μg/mL. The aqueous solution of the 2-methoxyethanol reference was stable within 5 days. Conclusion: The method is simple and environmental friendly. It has good system applicability, linearity, stability, precision and accuracy, and can be used for the determination of 2-methoxyethanol residues in polyethylene glycol monomethyl ether. |
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