Online-SPE法测定注射液中塑料包装可能迁移的四种抗氧化剂
Online-SPE method determination of 4 possible migration antioxidants in plastic packaging for injections
-
摘要: 本文为定量分析注射液中塑料包装可能迁移的4种抗氧化剂（168、330、1010和1076），建立了Turbo Flow固相萃取柱结合Hyperisil Gold分析柱的Online-SPE方法.借助DAD检测器和大体积自动进样器旁路时间调整，实现了对2000 μL样品的直接分析，并对2种塑料包装注射液样品进行了分析.结果表明，4种抗氧化剂的分辨率好、灵敏度高（LOD，0.7—2 μg·L-1）、线性良好（R > 0.999）、重现性好（RSD，5%—7%）、平均回收率104.5%—113.5%，适合大批量样品的分析测定.
-
关键词:
- 抗氧化剂 /
- Online-SPE方法 /
- 质量控制
Abstract: In order to quantitatively analyze the possible migration of four antioxidants in plastic packaging of injection: An online-SPE method of Turbo-flow solid phase extraction (SPE) column combined with hyperisil gold column was established. With adjustment of large volume injection auto-sampler bypass time, 2000 uL sample were directly analyzed,then two kinds of injection samples of plastic packaging were determined in this study. The results showing that the four antioxidants had good resolution, high sensitivity (LOD, 0.7-2 μg·L-1), good linearity (R> 0.999), and good reproducibility (RSD, 5%-7%). It is especially suitable for the analysis and determination of large quantities of samples.-
Key words:
- antioxidants /
- Online-SPE /
- quality control
-
-
[1] 刘兴兰, 王晓兰, 杨婧. LC-MS/MS测定注射用头孢噻肟钠包装所用胶塞中抗氧化剂1076的迁移量[J]. 药物分析杂志, 2017,37(11):2101-2105. LIU X L, WANG X L, YANG J. Determining migration of antioxidant 1076 in the packing rubber plug of cefotaxime sodium for injection by LC-MS/MS[J]. Chinese Journal of Pharmaceutical Analysis,2017,37(11):2101-2105(in Chinese).
[2] CUI P, WU J. Migration studies on the common antioxidants in rubber plug[J]. Chinese Journal of Pharmaceutical Analysis, 2016, 36(12):2231-2240. [3] 蒲小聪, 陈蕊, 游延军. HPLC法测定胶塞中抗氧化剂1076向米卡芬净钠注射液中的迁移[J]. 药物分析杂志, 2017, 37(7):1298-1303. PU X C, CHEN R, YOU Y J. HPLC determination for migration of antioxidant 1076 from rubber stopper to micafungin sodium injection[J]. Chinese Journal of Pharmaceutical Analysis, 2017, 37(7):1298-1303(in Chinese).
-
点击查看大图
计量
- 文章访问数: 1338
- HTML全文浏览数: 1338
- PDF下载数: 34
- 施引文献: 0
下载:
