| 引用本文: | 王丹丹,石倩暖,俞辉.GC-MS测定药用LDPE袋中2,2,4,6,6-五甲基庚烷含量及其迁移量[J].中国现代应用药学,2019,36(16):2049-2052. |
| WANG Dandan,SHI Qiannuan,YU Hui.Determination of 2,2,4,6,6-Pentamethyl Heptane in LDPE Bags and It's Migration by GC-MS[J].Chin J Mod Appl Pharm(中国现代应用药学),2019,36(16):2049-2052. |
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| GC-MS测定药用LDPE袋中2,2,4,6,6-五甲基庚烷含量及其迁移量 |
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王丹丹1, 石倩暖2, 俞辉1
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1.浙江省食品药品检验研究院, 浙江省药品接触材料质量控制研究重点实验室, 杭州 310052;2.浙江大学化学系, 杭州 310058
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| 摘要: |
| 目的 建立药用LDPE袋中2，2，4，6，6-五甲基庚烷含量及其向包装的原料药中迁移量的气相色谱-质谱测定法。方法 采用Stabilwax毛细管色谱柱（30 m×0.25 mm，0.25 μm）；柱温：60℃，离子源温度：240℃，接口温度260℃，流速1.0 mL·min-1。结果 2，2，4，6，6-五甲基庚烷在0.060 00~120.0 ng内呈良好的线性关系（r=0.999 6）；药用LDPE袋中2，2，4，6，6-五甲基庚烷含量测定的平均回收率为94.3%（RSD=3.8%）。结论 该方法准确、灵敏、简便，适用于对药用LDPE袋中2，2，4，6，6-五甲基庚烷含量及其向包装的原料药中迁移量的测定。 |
| 关键词: 气相色谱-质谱法 药用LDPE袋 2,2,4,6,6-五甲基庚烷 原料药 迁移量 |
| DOI：10.13748/j.cnki.issn1007-7693.2019.16.013 |
| 分类号:R917 |
| 基金项目:浙江省食品药品监管系统科技计划项目（YP201702） |
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| Determination of 2,2,4,6,6-Pentamethyl Heptane in LDPE Bags and It's Migration by GC-MS |
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WANG Dandan1, SHI Qiannuan2, YU Hui1
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1.Zhejiang Institute for Food and Drug Control, Key Laboratory of Drug Contacting Materials Quality Control of Zhejiang Province, Hangzhou 310052, China;2.Department of Chemistry of Zhejiang University, Hangzhou 310058, China
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| Abstract: |
| OBJECTIVE To develop a method for determination of 2,2,4,6,6-pentamethyl heptane in LDPE bags and migration into drugs by GC-MS. METHODS A Stabilwax column(30 m×0.25 mm, 0.25 μm) was adopted with 60℃ as column temperature. The ion source temperature was 240℃; the interface temperature was 260℃; the flow rate was 1.0 mL·min-1. RESULTS The method showed that 2,2,4,6,6-pentamethyl heptane had a linear range between 0.060 00-120.0 ng(r=0.999 6). The average recovery of 2,2,4,6,6-pentamethyl heptane in LDPE bag was 94.3% (RSD=3.8%). CONCLUSION This method is accurate, sensitive and simple, it can be used for determination of 2,2,4,6,6-pentamethyl heptane in LDPE bags and migration into drugs. |
| Key words: GC-MS LDPE bags 2,2,4,6,6-pentamethyl heptane drug migration |
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