Development and validation of methods for the determination of ethylene glycol and diethylene glycol impurities in soft dosage forms
- 作者: Paskar I.V.1, Senchenko S.P.1, Voroncova I.S.1, Borkovskaya E.V.1, Manturov D.S.1, Kiper R.A.1, Paskar N.G.2, Mezdrina M.A.3, Goncharova N.V.3
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隶属关系:
- LLC Scientific and testing center «FARMOBORONA»
- I.M. Sechenov First Moscow State Medical University, Ministry of Health of the Russian Federation (Sechenov University)
- JSC «AKRIHIN»
- 期: 卷 74, 编号 2 (2025)
- 页面: 14-22
- 栏目: Pharmaceutical chemistry and pharmacognosy
- URL: https://journal-vniispk.ru/0367-3014/article/view/290957
- DOI: https://doi.org/10.29296/25419218-2025-02-02
- ID: 290957
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Introduction. A number of excipients such as propylene glycol, sorbitol and glycerol used in the manufacture of soft dosage forms can be sources of toxic impurities of ethylene glycol and diethylene glycol. The content of these impurities must be controlled for the safe use of such pharmaceuticals. The high level of toxicity of ethylene glycol and diethylene glycol, low standards of their content, as well as the variety and complexity of the composition of dosage forms require the use of highly sensitive and selective analytical techniques.
Objective. Development and validation of methods for quantitative determination of ethylene glycol and diethylene glycol by gas chromatography in five samples of soft dosage forms of different composition.
Material and Methods. The object of the study was five samples of soft dosage forms. The composition of these pharmaceutical preparations includes propylene glycol and various macrogol compounds.
Results. Methods of quantitative determination of ethylene glycol and diethylene glycol by GC-FID method in five samples of soft dosage forms of different composition were developed. It was demonstrated that the differences in the composition of the studied objects require an individual approach to the analysis of these impurities - selection of chromatographic columns and temperature regimes, allowing to separate the analyzed components from the drug matrix. The applicability of the developed analytical methods for quantitative determination of ethylene glycol and diethylene glycol in the studied preparations was confirmed within the framework of validation experiments.
Conclusion. This study demonstrated the possibility of using the GC-FID method to control the content of impurities of ethylene glycol and diethylene glycol in five soft dosage forms of different composition.
作者简介
Irina Paskar
LLC Scientific and testing center «FARMOBORONA»
编辑信件的主要联系方式.
Email: paskar_irina@farmoborona.ru
Managing Director
俄罗斯联邦, 141074, Moscow region, Korolev, Gagarina str., 46ASergey Senchenko
LLC Scientific and testing center «FARMOBORONA»
Email: senchenko_sergey@farmoborona.ru
ORCID iD: 0000-0003-0212-3840
SPIN 代码: 4860-0144
Head of the Department of analytical methods development, Doctor of Pharmaceutical Sciences, Associate Professor
俄罗斯联邦, 141074, Moscow region, Korolev, Gagarina str., 46AIrina Voroncova
LLC Scientific and testing center «FARMOBORONA»
Email: voroncova_irina@farmoborona.ru
Pharmacist of the Department of аnalytical methods development
俄罗斯联邦, 141074, Moscow region, Korolev, Gagarina str., 46AEvgeniya Borkovskaya
LLC Scientific and testing center «FARMOBORONA»
Email: borkovskaya_evgeniya@farmoborona.ru
ORCID iD: 0000-0002-3095-6199
Senior Chemist of the Department of аnalytical methods development, Candidate of Chemical Sciences
俄罗斯联邦, 141074, Moscow region, Korolev, Gagarina str., 46ADmitry Manturov
LLC Scientific and testing center «FARMOBORONA»
Email: senchenko_sergey@farmoborona.ru
Chemist of the Department of аnalytical methods development
俄罗斯联邦, 141074, Moscow region, Korolev, Gagarina str., 46ARuslan Kiper
LLC Scientific and testing center «FARMOBORONA»
Email: kiper_ruslan@farmoborona.ru
Leading Chemist of the Department of аnalytical methods development
俄罗斯联邦, 141074, Moscow region, Korolev, Gagarina str., 46ANikita Paskar
I.M. Sechenov First Moscow State Medical University, Ministry of Health of the Russian Federation (Sechenov University)
Email: nnikpaskar@yandex.ru
5th year student of the Faculty of Pharmacy, A.P. Nelyubin Institute of Pharmacy
俄罗斯联邦, 119991, Moscow, 8, Trubetskaya st., page 2Marina Mezdrina
JSC «AKRIHIN»
Email: m.mezdrina@akrikhin.ru
Director of Drug Development Department
俄罗斯联邦, 142450, Staraya Kupavna, Moscow region, Bogorodsky urban district, Kirov St., 29Natalya Goncharova
JSC «AKRIHIN»
Email: n.goncharova@akrikhin.ru
ORCID iD: 0009-0009-5336-0409
head of the Chemical Analytical Research Division of the Drug Development Department
俄罗斯联邦, 142450, Staraya Kupavna, Moscow region, Bogorodsky urban district, Kirov St., 29参考
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