Development and validation of a gas chromatography method for the quantitative determination of ethylene glycol and diethylene glycol in effervescent tablets
- Authors: Paskar I.V.1, Senchenko S.P.1, Borkovskaya E.V.1, Voroncova I.S.1, Kiper R.A.1, Paskar N.G.2, Selezneva A.S.3, Bondarenko O.V.3
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Affiliations:
- LLC Research and testing center “FARMOBORONA”
- I.M. Sechenov First Moscow State Medical University, Ministry of Health of the Russian Federation (Sechenov University)
- LLC “Aristo Pharma”
- Issue: Vol 74, No 2 (2025)
- Pages: 29-37
- Section: Pharmaceutical chemistry and pharmacognosy
- URL: https://journals.eco-vector.com/0367-3014/article/view/677982
- DOI: https://doi.org/10.29296/25419218-2025-02-04
- ID: 677982
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Abstract
Introduction. Excipients used in the production of solid dosage forms may contain impurities of ethylene glycol and diethylene glycol, posing a potential risk to patient safety. Due to the high toxicity of these compounds and reported poisoning cases, their presence in pharmaceutical products must be strictly controlled. Currently, standardized analytical methods have been developed for liquid dosage forms, however, their application to other pharmaceutical forms requires adaptation, considering differences in composition and sample preparation.
Objective: to develop and validate a gas chromatography method for the quantitative determination of ethylene glycol and diethylene glycol in effervescent tablets.
Material and methods. The object of the study was effervescent tablets containing polyethylene glycol (PEG-6000) as an excipient. The analysis was carried out using a Chromateс Crystal 5000.2 gas chromatograph with a flame ionization detector. The validation included the assessment of specificity, linearity, LOQ, precision, accuracy, analytical range, robustness, and stability.
Results. The developed method ensures the selective determination of ethylene glycol and diethylene glycol in effervescent tablets. Optimized sample preparation conditions provide efficient extraction of target compounds. During validation, the method was confirmed to meet the established criteria for all evaluated parameters. The method is applicable for the quantitative determination of ethylene glycol and diethylene glycol in the concentration range from LOQ to 150% of the specification level. However, due to the limited stability of solutions, it is necessary to strictly adhere to the specified storage conditions.
Conclusion. A gas chromatography method with flame ionization detection has been developed and validated for the quantitative determination of ethylene glycol and diethylene glycol in effervescent tablets. The method meets the established requirements and can be used for quality control of solid dosage forms.
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About the authors
Irina Vladimirovna Paskar
LLC Research and testing center “FARMOBORONA”
Author for correspondence.
Email: paskar_irina@farmoborona.ru
Managing Director, Candidate of Pharmaceutical Sciences
Russian Federation, Gagarina str., 46 A, Korolev, Moscow region, 141074Sergey Petrovich Senchenko
LLC Research 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, Gagarina str., 46 A, Korolev, Moscow region, 141074Evgeniya Vladimirovna Borkovskaya
LLC Research 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, Gagarina str., 46 A, Korolev, Moscow region, 141074Irina Sergeevna Voroncova
LLC Research and testing center “FARMOBORONA”
Email: voroncova_irina@farmoborona.ru
Pharmacist of the Department of аnalytical methods development
Russian Federation, Gagarina str., 46 A, Korolev, Moscow region, 141074Ruslan Anatolievich Kiper
LLC Research and testing center “FARMOBORONA”
Email: kiper_ruslan@farmoborona.ru
Leading Chemist of the Department of аnalytical methods development
Russian Federation, Gagarina str., 46 A, Korolev, Moscow region, 141074Nikita 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, Trubetskaya str., 8, build. 2, Mosсow, 119991Alina Sergeevna Selezneva
LLC “Aristo Pharma”
Email: alina.selezneva@aristo-pharma.ru
Manager of the Registration Department
Russian Federation, Leningradskoe shosse, 16A, build. 3, Moscow, 125171Olga Vladimirovna Bondarenko
LLC “Aristo Pharma”
Email: olga.bondarenko@aristo-pharma.ru
ORCID iD: 0000-0001-8240-5201
Manager of the Registration Department, Candidate of Pharmaceutical Sciences
Russian Federation, Leningradskoe shosse, 16A, build. 3, Moscow, 125171References
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