Research on Extraction and Migration of Six Polycyclic Aromatic Hydrocarbons from Plastic Components Used in Production of Propyl Gallate Injections by HPLC-FLD

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  • Shandong Provincial Key Laboratory of Chemical Drugs, Shandong Academy of Pharmaceutical Sciences, Jinan 250101 , China

Online published: 2022-08-11

Abstract

Objective: Under the requirements of “Technical Guide for the Compatibility Study of the Plastic Component System Used in Production of Chemical Drug Injections (Trial)” and “Technical Guidelines for the Study of Compatibility Between Chemicals and Elastomer Seals (Trial)”, simulated extraction and safety evaluation of six polycyclic aromatic hydrocarbons that may be contained in the plastic components used in production were carried out. The relevant components in the downstream product of propyl gallate Injections were determined by the migration test. Methods: Kromasil 100-5-C18 (4.6 mm×250 mm, 5 μm) chromatographic column was used and the high performance liquid chromatography-fluorescence detection method (HPLCFLD) was performed, injection volume was 60 μL and the column temperature was 35°C with acetonitrile-water (70∶30, v/v) as mobile phase at the fl ow rate of 1.2 mL·min-1. The excitation wavelengths of fl uorescence detector were 270 nm (naphthalene), 250 nm (phenanthrene, anthracene), 238 nm (pyrene), 286 nm (benzo[α] anthracene) and 262 nm (benzo[α] pyrene) respectively, and the emission wavelengths were 335 nm (naphthalene), 380 nm (phenanthrene, anthracene), 390 nm (pyrene), 397 nm (benzo[α] anthracene) and 413 nm (benzo[α] pyrene) respectively. Results: The six PAHs had a good linear relationship within their respective concentration range (r≥0.9979), and the detection limits were in the range of 0.005-0.037 ng. The recoveries were in the range of 99.86%-102.16%. RSDs were no more than 4% (n=9). The extraction test results of seals showed that multiple PAHs could be detected in 50% ethanol solutions, while a trace of naphthalene could be detected in pH10 buff ers and HTHP (high temperature and high pressure) extracts of injection. The result of injection migration test showed that the propyl gallate Injections could be only migrated into trace naphthalene, and the migration amount was far lower than analytical evaluation threshold (AET). Conclusion: The HPLC-FLD method used in the experiment is simple, accurate, specifi c, and sensitive. It can be used to determine the content of six PAHs in the simulated extraction and Injections of plastic components used in production.

Cite this article

Yu Liang, Zhang Wen, Li Zhaoming, Zhang Lin, Yan Hong, Liu Lin, Xu Weina, Liu Yan, Zhang Daizhou, Liu Kuikui . Research on Extraction and Migration of Six Polycyclic Aromatic Hydrocarbons from Plastic Components Used in Production of Propyl Gallate Injections by HPLC-FLD[J]. Chinese Pharmaceutical Affairs, 2022 , 36(8) : 934 -942 . DOI: 10.16153/j.1002-7777.2022.08.011

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