Shenyang Xingqi Pharmaceutical Co.,Ltd., Shenyang 110163, China.
Liaoning Institute of Traditional Chinese Medicine, Shenyang 110034,China.
J Pharm Biomed Anal. 2023 Oct 25;235:115591. doi: 10.1016/j.jpba.2023.115591. Epub 2023 Jul 20.
Although the secondary packing materials do not directly contact the finished drug products, compound migration may still happen between them. To ensure drug quality and safety, extractables and leachables of the packing materials should be analyzed. In this study, 2,6-di-tert-butyl-4-methylphenol (BHT) was first found in the labels for pharmaceutical packaging. For the identification of the compound, a strategy combining high performance liquid chromatography (HPLC), ultra-performance liquid chromatography-quadrupole time-of-flight mass (UPLC-Q-TOF-MS) and nuclear magnetic resonance (NMR) spectroscopy was utilized. Afterwards, a effective and sensitive HPLC method for quantification of BHT was developed and validated. Finally, a toxicological risk assessment of BHT was performed to ensure the safety of drugs.
虽然二次包装材料不会直接接触到成品药物，但它们之间仍可能发生化合物迁移。为了确保药物质量和安全，应分析包装材料的浸出物和可提取物。在这项研究中，首次在药品包装标签中发现了 2,6-二叔丁基-4-甲基苯酚（BHT）。为了鉴定该化合物，采用了高效液相色谱（HPLC）、超高效液相色谱-四极杆飞行时间质谱（UPLC-Q-TOF-MS）和核磁共振（NMR）光谱相结合的策略。随后，建立并验证了一种用于定量测定 BHT 的高效液相色谱法。最后，对 BHT 进行了毒理学风险评估，以确保药物的安全性。
