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

Determination of 2,2,4,6,6-Pentamethyl Heptane in LDPE Bags and It's Migration by GC-MS

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。

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.