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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Main Authors: Xun Gao, Kexin Chen, Miaomiao Chi, Kunming Qin
Format: Article
Language:English
Published: Wiley 2020-01-01
Series:International Journal of Analytical Chemistry
Online Access:http://dx.doi.org/10.1155/2020/9760580
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author Xun Gao
Kexin Chen
Miaomiao Chi
Kunming Qin
author_facet Xun Gao
Kexin Chen
Miaomiao Chi
Kunming Qin
author_sort Xun Gao
collection DOAJ
description 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.
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id doaj-art-15bbe5d38f8f48deb4062bccf9e33adc
institution Kabale University
issn 1687-8760
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language English
publishDate 2020-01-01
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record_format Article
series International Journal of Analytical Chemistry
spelling doaj-art-15bbe5d38f8f48deb4062bccf9e33adc2025-02-03T01:05:04ZengWileyInternational Journal of Analytical Chemistry1687-87601687-87792020-01-01202010.1155/2020/97605809760580Methyl 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 InjectionsXun Gao0Kexin Chen1Miaomiao Chi2Kunming Qin3School of Pharmacy, Jiangsu Key Laboratory of Marine Pharmaceutical Compound Screening, Co-Innovation Center of Jiangsu Marine Bio-industry Technology, Jiangsu Ocean University, 59 Cangwu Road Haizhou District, Lianyungang, Jiangsu, ChinaSchool of Pharmacy, Jiangsu Key Laboratory of Marine Pharmaceutical Compound Screening, Co-Innovation Center of Jiangsu Marine Bio-industry Technology, Jiangsu Ocean University, 59 Cangwu Road Haizhou District, Lianyungang, Jiangsu, ChinaSchool of Pharmacy, Jiangsu Key Laboratory of Marine Pharmaceutical Compound Screening, Co-Innovation Center of Jiangsu Marine Bio-industry Technology, Jiangsu Ocean University, 59 Cangwu Road Haizhou District, Lianyungang, Jiangsu, ChinaSchool of Pharmacy, Jiangsu Key Laboratory of Marine Pharmaceutical Compound Screening, Co-Innovation Center of Jiangsu Marine Bio-industry Technology, Jiangsu Ocean University, 59 Cangwu Road Haizhou District, Lianyungang, Jiangsu, ChinaA 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.http://dx.doi.org/10.1155/2020/9760580
spellingShingle Xun Gao
Kexin Chen
Miaomiao Chi
Kunming Qin
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
International Journal of Analytical Chemistry
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
url http://dx.doi.org/10.1155/2020/9760580
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AT kexinchen methylesterificationcombinedwithgaschromatographymassspectrometrygcmsfordeterminingthecontentsoflubricanttoevaluatethecompatibilityofchlorinatedbutylrubberstopperswithliposomeinjections
AT miaomiaochi methylesterificationcombinedwithgaschromatographymassspectrometrygcmsfordeterminingthecontentsoflubricanttoevaluatethecompatibilityofchlorinatedbutylrubberstopperswithliposomeinjections
AT kunmingqin methylesterificationcombinedwithgaschromatographymassspectrometrygcmsfordeterminingthecontentsoflubricanttoevaluatethecompatibilityofchlorinatedbutylrubberstopperswithliposomeinjections