Abstract
A simple, sensitive, and exact methyl esterification in combination with gas chromatography-mass spectrometry (GC-MS) method was developed to determine the contents of palmitic acid and stearic acid in the chlorinated butyl rubber stoppers and liposome injections in order to evaluate the compatibility of pharmaceutical packaging materials. In this experiment, palmitic acid and stearic acid were detected in the form of methyl hexadecanoate and methyl stearate in chlorinated butyl rubber stoppers and liposome injections. The results showed good linearities in the range of 0.50–10.00 µg·mL−1 for methyl hexadecanoate and 1.00–20.00 µg·mL−1 for methyl stearate, with the limits of detection (LOD) 11.94 ng·mL−1 and 11.90 ng·mL−1, respectively. The recoveries that ranged from 95.25% to 100.29% were satisfied, and the relative standard deviation (RSD) was no more than 7.16%. The developed method was successfully applied to evaluate the compatibility of chlorinated butyl rubber stoppers with liposome injections and the safety assessment.
Highlights
International Journal of Analytical Chemistry and soft coating might be applied to cover the outer surface of the rubber stoppers to improve the compatibility of them
There are capillary electrophoresis (CE), near-infrared absorption spectroscopy (NTR), ultraviolet-visible spectrophotometry (UV-VIS), Raman spectroscopy (Ram), nuclear magnetic resonance spectroscopy (NMRS), and so on. in layer chromatography is only used in the pretreatment stage of gas chromatography (GC) and LC, and there are no reports for the separate analysis of fatty acids
Is process is called methylation [19, 20]. e reagents most used in acid catalysis esterification are hydrochloric acid (HCl), sulfuric acid (H2SO4), and boron trifluoride (BF3) in methanol [21]. e reaction time of BF3 method is short and the reaction temperature is moderate so that the unsaturated fatty acids will not be destroyed. e advantage of this method is that the methyl esterification of fatty acids is complete, and it is suitable for the methyl esterification of free fatty acids. us, BF3 method is more suitable for the analysis of stearic acid and palmitic acid, which is a methyl esterification process in Chinese Pharmacopoeia [22]
Summary
International Journal of Analytical Chemistry and soft coating might be applied to cover the outer surface of the rubber stoppers to improve the compatibility of them. Erefore, it is considered to determine the content of stearic acid in chlorinated butyl rubber stoppers. LC-MS is often used to determine many kinds of fatty acids at the same time or to study liposome It is the main method for lipid research. Us, BF3 method is more suitable for the analysis of stearic acid and palmitic acid, which is a methyl esterification process in Chinese Pharmacopoeia [22]. In the process of sample treatment, palmitic acid and stearic acid in chlorinated butyl rubber plug were derivatized into volatile methyl ester compounds with methyl palmitate and stearic acid as control, and GC-MS analysis was carried out, which effectively solved the problem that stearic acid was not easy to be directly analyzed by GC-MS
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