Shenyang Xingqi Pharmaceutical Co., Ltd., Shenyang 110163, China.
Department of Pharmacy, General Hospital of Northern Theater Command, No.5, Guangrong Street, Heping District, Shenyang 110000, China.
J Pharm Biomed Anal. 2022 Oct 25;220:115015. doi: 10.1016/j.jpba.2022.115015. Epub 2022 Aug 23.
Extractables and leachables from pharmaceutical packaging material can potentially be detrimental, which may affect the safety of the drug products. In this study, two compounds were found to be the possible extractables from the secondary packaging material. A strategy combining high performance liquid chromatography (HPLC), fourier transform ion cyclotron resonance mass spectrometry (FT-ICR-MS) and nuclear magnetic resonance (NMR) spectroscopy was utilized for identification of the two compounds. Afterwards, a simple and sensitive HPLC method was developed and validated for the simultaneous quantification of both. The results indicated that this method was suitable for quantificating the two extractables in the pharmaceutical packaging material.
药品包装材料中的浸出物和可提取物可能具有危害性，这可能会影响药品的安全性。在这项研究中，从二次包装材料中发现了两种可能的浸出物。本研究采用高效液相色谱（HPLC）、傅里叶变换离子回旋共振质谱（FT-ICR-MS）和核磁共振（NMR）光谱相结合的策略，对这两种化合物进行了鉴定。之后，建立并验证了一种简单灵敏的 HPLC 方法，用于同时定量这两种物质。结果表明，该方法适用于定量药品包装材料中的两种浸出物。
