文章摘要
成婕,蒲小聪,张罗红,柏金枝,范建伟,关永霞,杨剑,江燕.UPLC-MS/MS法筛查口服液体药用复合膜中12种常见抗氧剂[J].包装工程,2024,45(11):226-233.
CHENG Jie,PU Xiaocong,ZHANG Luohong,BAI Jinzhi,FAN Jianwei,GUAN Yongxia,YANG Jian,JIANG Yan.Screening of 12 Common Antioxidants in Oral Liquid Medicinal Composite Films by Ultra Performance Liquid Chromatography Tandem Mass Spectrometry[J].Packaging Engineering,2024,45(11):226-233.
UPLC-MS/MS法筛查口服液体药用复合膜中12种常见抗氧剂
Screening of 12 Common Antioxidants in Oral Liquid Medicinal Composite Films by Ultra Performance Liquid Chromatography Tandem Mass Spectrometry
投稿时间:2023-12-25  
DOI:10.19554/j.cnki.1001-3563.2024.11.027
中文关键词: 超高效液相色谱-串联质谱(UPLC-MS/MS)  抗氧剂  口服液体药用复合膜  筛查
英文关键词: UPLC-MS/MS  antioxidants  oral liquid medicinal composite films  screening
基金项目:四川药品监督管理局科技计划项目(2023008)
作者单位
成婕 四川省药品检验研究院 工业和信息化部产业技术基础公共服务平台成都 611731 
蒲小聪 四川省药品检验研究院 工业和信息化部产业技术基础公共服务平台成都 611731 
张罗红 四川省药品检验研究院 工业和信息化部产业技术基础公共服务平台成都 611731 
柏金枝 四川汇利实业有限公司成都 611731 
范建伟 鲁南制药集团股份有限公司山东 临沂 276005 
关永霞 鲁南制药集团股份有限公司山东 临沂 276005 
杨剑 四川省药品检验研究院 工业和信息化部产业技术基础公共服务平台成都 611731 
江燕 四川省药品检验研究院 工业和信息化部产业技术基础公共服务平台成都 611731 
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中文摘要:
      目的 建立超高效液相色谱-串联质谱法(UPLC-MS/MS),用于筛查口服液体药用复合膜中12种常见抗氧剂。方法 采用正己烷为提取溶剂,回流2 h,提取目标化合物,用超高效液相色谱-串联质谱(UPLC-MS/MS)检测目标化合物含量;以Shim-pack GIST C18(100 mm×2.1 mm, 2 μm)为色谱柱,甲醇和水为流动相;质谱选用电喷雾(ESI)离子源,多反应监测(MRM)正离子模式进行定性定量分析。结果 12种抗氧剂在2~500 ng/mL的质量浓度范围内线性良好,相关系数r≥0.998 6,检测限为0.2~10.6 ng/g,回收率为78.9%~112.7%,相对标准偏差(RSD)为0.8%~7.0%(n=3);经检测,12批口服液体药用复合膜中均有抗氧剂检出,其中含量较高的有1010、1076和168。结论 该方法高效灵敏、准确可靠,可用于口服液体药用复合膜中12种常见抗氧剂的筛查。
英文摘要:
      The work aims to establish an ultra-performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method to screen 12 common antioxidants in oral liquid medicinal composite films. With n-hexane as the extraction solvent, the target compounds were extracted through a 2-hour reflux process. The content of the target compounds was then analyzed by ultra-performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS). Shim-pack GIST C18 (100 mm×2.1 mm, 2 μm) was employed as the chromatographic column and methanol and water were used as the mobile phase. Electrospray ionization (ESI) was utilized as the ion source, and multiple reaction monitoring (MRM) in positive ion mode was applied for qualitative and quantitative analysis. The 12 antioxidants exhibited good linearity within the concentration range of 2 to 500 ng/mL, with a correlation coefficient (r) ≥ 0.998 6. The detection limits ranged from 0.2 to 10.6 ng/g, and the recovery rates were between 78.9% and 112.7%. The relative standard deviation (RSD) ranged from 0.8% to 7.0% (n=3). Upon analysis, antioxidants were detected in all 12 batches of oral liquid medicinal composite films, with higher concentrations found in samples 1010, 1076, and 168. This method is highly efficient, sensitive, accurate, and reliable, making it suitable for the screening of 12 common antioxidants in oral liquid medicinal composite films.
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