Determination of Antioxidant 264 in the Butyl Rubber Stopper and the Compatibility with Recombinant Potent Antitumor and Antivirus Protein Injection
Objective. 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). Methods. Dichloromethane-ethan...
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| Format: | Article |
| Language: | English |
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Wiley
2020-01-01
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| Series: | Journal of Analytical Methods in Chemistry |
| Online Access: | http://dx.doi.org/10.1155/2020/8827925 |
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| author | Min Zhao Xianhui Li Di Zhang Longshan Zhao |
| author_facet | Min Zhao Xianhui Li Di Zhang Longshan Zhao |
| author_sort | Min Zhao |
| collection | DOAJ |
| description | Objective. 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). Methods. 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. Results. The linearity range was from 4.003 to 200.150 μg/mL (r2 = 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. Conclusion. 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. |
| format | Article |
| id | doaj-art-9dd07cdea6b64d21ae9b4e949cce028a |
| institution | Kabale University |
| issn | 2090-8865 2090-8873 |
| language | English |
| publishDate | 2020-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Analytical Methods in Chemistry |
| spelling | doaj-art-9dd07cdea6b64d21ae9b4e949cce028a2025-02-03T01:04:08ZengWileyJournal of Analytical Methods in Chemistry2090-88652090-88732020-01-01202010.1155/2020/88279258827925Determination of Antioxidant 264 in the Butyl Rubber Stopper and the Compatibility with Recombinant Potent Antitumor and Antivirus Protein InjectionMin Zhao0Xianhui Li1Di Zhang2Longshan Zhao3School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, ChinaSchool of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, ChinaShenyang Wellwolf Pharmaceutical Science and Technology Co. Ltd., Shenyang 110022, ChinaSchool of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, ChinaObjective. 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). Methods. 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. Results. The linearity range was from 4.003 to 200.150 μg/mL (r2 = 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. Conclusion. 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.http://dx.doi.org/10.1155/2020/8827925 |
| spellingShingle | Min Zhao Xianhui Li Di Zhang Longshan Zhao Determination of Antioxidant 264 in the Butyl Rubber Stopper and the Compatibility with Recombinant Potent Antitumor and Antivirus Protein Injection Journal of Analytical Methods in Chemistry |
| title | Determination of Antioxidant 264 in the Butyl Rubber Stopper and the Compatibility with Recombinant Potent Antitumor and Antivirus Protein Injection |
| title_full | Determination of Antioxidant 264 in the Butyl Rubber Stopper and the Compatibility with Recombinant Potent Antitumor and Antivirus Protein Injection |
| title_fullStr | Determination of Antioxidant 264 in the Butyl Rubber Stopper and the Compatibility with Recombinant Potent Antitumor and Antivirus Protein Injection |
| title_full_unstemmed | Determination of Antioxidant 264 in the Butyl Rubber Stopper and the Compatibility with Recombinant Potent Antitumor and Antivirus Protein Injection |
| title_short | Determination of Antioxidant 264 in the Butyl Rubber Stopper and the Compatibility with Recombinant Potent Antitumor and Antivirus Protein Injection |
| title_sort | determination of antioxidant 264 in the butyl rubber stopper and the compatibility with recombinant potent antitumor and antivirus protein injection |
| url | http://dx.doi.org/10.1155/2020/8827925 |
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