Chu Liu, Xiangyong Yu, Zhaorui Meng
Nov 14, 2019
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Journal
Biomedical chromatography : BMC
Abstract
A simple and efficient method involving microwave assisted extraction (MAE) combined with GC-MS was established to determine 1,3-Di-tert-butylbenzene (DBB), 2,4-Di-tert-butylphenol (DBP), 3,5-Di-tert-butyl-4-hydroxybenzaldehyde (DBHBA), for the purpose of evaluating the compatibility with drug packaging materials. In this study, the antimicrobial peptide PL-5 spray was purified by a Welchrom® C18 column and the high density polyethylene spray bottle with liquid collection tube was firstly mixed with absolute ethanol, which would be subjected to MAE for further measurement by GC-MS. Various experimental parameters were systematically optimized and good linearities were obtained within the range of 0.05-1.00 μg/ml for DBB and DBHBA and 0.50-10.00 μg/ml for DBP, with limits of detection (LOD) of 0.99 ng/ml (DBB), 16.34 ng/ml (DBP) and 1.64 ng/ml (DBHBA), respectively. Satisfactory recoveries that ranged from 96.0 % to 107.2 % were acquired and the relative standard deviation (RSD) was no more than 4.7 %. The results showed that the maximum daily usage of DBB, DBP and DBHBA were 9.859 ng, 163.445 ng and 16.399 ng, respectively, which were far below the corresponding PDE values according to the safety assessment, indicating that the migration of analytes did not bring any potential safety risk. The compatibility between the drug and the packaging materials was favorable.