Zhao Min, Li Xianhui, Zhang Di, Zhao Longshan
School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China.
Shenyang Wellwolf Pharmaceutical Science and Technology Co. Ltd., Shenyang 110022, China.
J Anal Methods Chem. 2020 Sep 9;2020:8827925. doi: 10.1155/2020/8827925. eCollection 2020.
To establish a method for extraction and determination of antioxidant 264 (2,6-di-tert-butyl-4-methylphenol) in the brominated butyl rubber stopper for injection and migration study in recombinant potent antitumor and antivirus protein injection (Novaferon).
Dichloromethane-ethanol was adopted as the extraction solvent during the process of reflux extraction of antioxidant 264 in the brominated butyl rubber stopper. High-performance liquid chromatography (HPLC) was used for the determination of the migration of antioxidant 264 to Novaferon. The mobile phase consisted of acetonitrile-water (80 : 20, v/v). The flow rate was 1.5 mL/min. The detection wavelength was 280 nm.
The linearity range was from 4.003 to 200.150 g/mL ( = 0.99996), and the average recovery of antioxidant 264 was 97.8%. The applicability of the methodology was good, which can be used for the determination of antioxidant 264. The results indicated that antioxidant 264 was not detected in Novaferon after the accelerated test and three months of long-term test.
The established validated method in this study can be used for the determination of antioxidant 264 in the rubber stopper, and the brominated butyl rubber stopper has good compatibility with Novaferon.
建立一种提取和测定注射用溴化丁基橡胶塞中抗氧化剂264（2,6-二叔丁基-4-甲基苯酚）的方法，并研究其在重组高效抗肿瘤及抗病毒蛋白注射液（新福康里）中的迁移情况。
采用二氯甲烷 - 乙醇作为提取溶剂，对溴化丁基橡胶塞中的抗氧化剂264进行回流提取。采用高效液相色谱法（HPLC）测定抗氧化剂264向新福康里中的迁移量。流动相为乙腈 - 水（80∶20，v/v）。流速为1.5 mL/min。检测波长为280 nm。
线性范围为4.003～200.150 μg/mL（r = 0.99996），抗氧化剂264的平均回收率为97.8%。该方法适用性良好，可用于抗氧化剂264的测定。结果表明，加速试验和3个月长期试验后，新福康里中未检测到抗氧化剂264。
本研究建立的经验证方法可用于测定橡胶塞中抗氧化剂264，溴化丁基橡胶塞与新福康里具有良好的相容性。
