Methyl Esterification Combined with Gas Chromatography-Mass Spectrometry (GC-MS) for Determining the Contents of Lubricant to Evaluate the Compatibility of Chlorinated Butyl Rubber Stoppers with Liposome Injections

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 compatibili...

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Bibliographic Details
Published in:International journal of analytical chemistry 2020, Vol.2020 (2020), p.1-9
Main Authors: Qin, Kunming, Chi, Miaomiao, Chen, Kexin, Gao, Xun
Format: Article
Language:English
Subjects:
Analytical chemistry
Butyl rubber
Chlorination
Chromatography
Compatibility
Esterification
Evaluation
Fatty acids
Fourier transforms
Gas chromatography
Lubricants & lubrication
Mass spectrometry
Methods
NMR
Nuclear magnetic resonance
Palmitic acid
Pharmaceuticals
Quality standards
Raw materials
Reagents
Rubber
Scientific imaging
Spectroscopy
Stearic acid
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Summary: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.
ISSN:1687-8760
1687-8779
DOI:10.1155/2020/9760580