Development and validation of methods for the determination of ethylene glycol and diethylene glycol impurities in soft dosage forms
- Authors: 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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Affiliations:
- 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»
- Issue: Vol 74, No 2 (2025)
- Pages: 14-22
- Section: Pharmaceutical chemistry and pharmacognosy
- URL: https://journals.eco-vector.com/0367-3014/article/view/677973
- DOI: https://doi.org/10.29296/25419218-2025-02-02
- ID: 677973
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Abstract
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.
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About the authors
Irina Vladimirovna Paskar
LLC Scientific and testing center «FARMOBORONA»
Author for correspondence.
Email: paskar_irina@farmoborona.ru
Managing Director
Russian Federation, 141074, Moscow region, Korolev, Gagarina str., 46ASergey Petrovich Senchenko
LLC Scientific and testing center «FARMOBORONA»
Email: senchenko_sergey@farmoborona.ru
ORCID iD: 0000-0003-0212-3840
SPIN-code: 4860-0144
Head of the Department of analytical methods development, Doctor of Pharmaceutical Sciences, Associate Professor
Russian Federation, 141074, Moscow region, Korolev, Gagarina str., 46AIrina Sergeevna Voroncova
LLC Scientific and testing center «FARMOBORONA»
Email: voroncova_irina@farmoborona.ru
Pharmacist of the Department of аnalytical methods development
Russian Federation, 141074, Moscow region, Korolev, Gagarina str., 46AEvgeniya Vladimirovna 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
Russian Federation, 141074, Moscow region, Korolev, Gagarina str., 46ADmitry Sergeevich Manturov
LLC Scientific and testing center «FARMOBORONA»
Email: senchenko_sergey@farmoborona.ru
Chemist of the Department of аnalytical methods development
Russian Federation, 141074, Moscow region, Korolev, Gagarina str., 46ARuslan Anatolievich Kiper
LLC Scientific and testing center «FARMOBORONA»
Email: kiper_ruslan@farmoborona.ru
Leading Chemist of the Department of аnalytical methods development
Russian Federation, 141074, Moscow region, Korolev, Gagarina str., 46ANikita Grigorievich 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
Russian Federation, 119991, Moscow, 8, Trubetskaya st., page 2Marina Aleksandrovna Mezdrina
JSC «AKRIHIN»
Email: m.mezdrina@akrikhin.ru
Director of Drug Development Department
Russian Federation, 142450, Staraya Kupavna, Moscow region, Bogorodsky urban district, Kirov St., 29Natalya Victorovna 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
Russian Federation, 142450, Staraya Kupavna, Moscow region, Bogorodsky urban district, Kirov St., 29References
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