文章摘要
张晓芸,丁逸梅,刘露遥.RP-HPLC法测定药用胶塞中16种多环芳烃含量 并作模拟提取研究[J].药学与临床研究,2020,28(3):170~174
RP-HPLC法测定药用胶塞中16种多环芳烃含量 并作模拟提取研究
Determination of 16 Polycyclic Aromatic Hydrocarbons in Pharmaceutical Rubber Plugs by RP-HPLC and Thier Migration
投稿时间:2019-09-26  修订日期:2020-06-16
DOI:
中文关键词: 多环芳烃  高效液相色谱法  橡胶胶塞  迁移实验  橡胶胶塞
英文关键词: Polycyclic aromatic hydrocarbon  HPLC chromatography  Pharmaceutical Rubber Plugs  Rubber
基金项目:
作者单位E-mail
张晓芸 江苏省药物研究所有限公司 yunlovers@163.com 
丁逸梅 江苏省药物研究所有限公司 908520694@qq.com 
刘露遥 江苏省药物研究所有限公司  
摘要点击次数: 650
全文下载次数: 614
中文摘要:
      目的:本试验通过高效液相色谱法测定药用胶塞中16 种多环芳烃(PAHs)的含量并作迁移试验。方法:色谱柱为Kromasil 100-5-C18 (4.6 mm × 250 mm,5 μm);以乙腈和水为流动相,采用梯度洗脱进行分离:0~27 min,乙腈-水(65∶35);27~41 min,乙腈-水(65∶35)→(100∶0);41~43 min,乙腈-水(100∶0)→(65∶35);43~55 min,乙腈-水(65∶35)。检测波长:220、254、295 nm。结果:16种PAHs在0.1000~10.00 μg·mL-1浓度范围内线性关系良好,均r≥0.999;定量限在2.505~83.20 ng·mL-1;检测限在0.751 5~24.96 ng·mL-1;精密度RSD均≤2.0%;重复性RSD≤3.0%;平均加样回收率为88.74%~99.27%。试验同时考察16 种多环芳烃(PAHs)的迁移试验,以验证该方法。结论:试验采用的RP-HPLC法测定16种PAHs方法专属性良好,能够快捷、简便、准确、灵敏地测定药用胶塞中16种PAHs的含量,可适用于橡胶胶塞中 PAHs的测定以及考察注射液中16种PAHs的迁移。
英文摘要:
      Objective: To establish a HPLC method for the determination of 16 polycyclic aromatic hydrocarbons (PAHs) in rubber plugs and to test their migration. Methods: A Kromasil 100-5-C18 (4.6 mm × 250 mm, 5 μm) column under gradient elution was used for separation; PAHs from the rubber plugs were extracted through ultrasonics and the analysis was tested for linearity, LOD, LQD, precision, repeatability and recovery. Results: A good linear relationship were obtained when the concentrations of the 16 PAHs were within the ranges, with the correlative coefficient r>0.999; LQD were at 2.505-83.20 ng·mL-1; LOD were at 0.751 5-24.96 ng·mL-1; RSD for precision were less than 2.0%, repeatability RSD were less than 3.0%; The average recovery were at 88.74%-99.27%. The migration of the 16 PAHs were tested to verify the specificity of the method. Conclusion: In this study, the method established is rapid, simple, accurate and reliable for the determination of PAHs in the rubber plugs and their migration in injections to ensure drug safety.
查看全文   查看/发表评论  下载PDF阅读器
关闭