Partial validation of the chromato-mass-spectrometric methodology for the determination of carbon sulfur in infusion medicines
- Authors: Selyutin O.A.1,2, Shatalov D.O.3,4, Pisarev D.I.5, Novikov O.O.6, Zhilyakova E.T.7, Chichulina V.V.8, Gromakova A.I.9, Davydova V.N.9, Sahno N.V.10
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Affiliations:
- ITCT named after M.V. Lomonosov, MIREA - Russian Technological University
- Voronezh Regional Clinical Oncological Dispensary
- ITCT named after M.V. Lomonosov, MIREA – Russian Technological University
- Institute of Pharmaceutical Technologies JSC
- People's Friendship University of Russia
- Peoples' Friendship University
- Belgorod State National Research University
- ITCT. M.V. Lomonosov, Russian Technological University
- All-Russian Scientific Research Institute of Medicinal and Aromatic Plants
- Oryol state agrarian University named after N.V. Parakhina
- Issue: Vol 26, No 2 (2023)
- Pages: 16-22
- Section: Pharmaceutical chemistry
- URL: https://journals.eco-vector.com/1560-9596/article/view/248031
- DOI: https://doi.org/10.29296/25877313-2023-02-02
- ID: 248031
Cite item
Abstract
Relevance. Nowadays the standardization and control of medicines to provide the consumer with high-quality pharmaceutical products is an important issue. The use of parenteral medicines is associated with the potential risk of exposure to the patient's body of carbon disulfide, which is contained in rubber plugs and can pose a serious health hazard.
The purpose of this article is to conduct partial validation of the developed methodology for quantification of carbon disulfide impurities in infusion dosage forms by chromato-mass spectrometry.
Material and methods. The model solution was the drug "Reopoliglyukin, solution for infusion" (JSC BIOCHEMIK, Russia). Methyl ethyl sulfide, 99% (NevaReaktiv, Russia) was used as an internal standard. The measurements were carried out on a chromatography-mass spectrometer model GCMS-QP2010 Ultra, manufactured by Shimadzu, Japan.
Results. The process of sample preparation is described, also the acceptance criteria for determining specificity, linearity, accuracy and limit of quantification were set. The chromatograms and results obtained for the model sample "Rheopolyglucin, solution for infusion" are presented, the coincidence of the peak areas in terms of retention times for the model sample and carbon disulfide, as well as the internal standard, allows us to state that the method meets the requirements for the "Specificity" indicator. The necessary calculations were made to confirm that the analytical methodology is linear. The limit of quantitation was found experimentally by means of a series of dilutions. The correctness was confirmed using the method of additions.
Conclusion. The measures taken made it possible to carry out a partial validation of the analytical methodology for determining carbon disulfide impurities in infusion drugs. It has been determined that all the results obtained meet the indicated acceptance criteria within the selected range of characteristics. Also, it was confirmed that in the indicated concentrations, the methodology has no system error.
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About the authors
O. A. Selyutin
ITCT named after M.V. Lomonosov, MIREA - Russian Technological University; Voronezh Regional Clinical Oncological Dispensary
Author for correspondence.
Email: selutinoa@yandex.ru
Applicant, Department of Biotechnology and Industrial Pharmacy; Deputy Chief Physician for Clinical Research and Innovative Technologies
Russian Federation, Moscow; VoronezhD. O. Shatalov
ITCT named after M.V. Lomonosov, MIREA – Russian Technological University; Institute of Pharmaceutical Technologies JSC
Email: shat-05@mail.ru
Ph.D. (Pharm.), Associate Professor of the Department of Biotechnology and Industrial Pharmacy; Deputy General Director
Russian Federation, Moscow; MoscowD. I. Pisarev
People's Friendship University of Russia
Email: juniper05@mail.ru
Dr.Sc. (Pharm.), Associate Professor, Professor of the Agrarian and Technological Institute
Russian Federation, MoscowO. O. Novikov
Peoples' Friendship University
Email: ole9222@yandex.ru
Dr.Sc. (Pharm.), Professor, Deputy Director for Scientific and Educational Work, NORC Pharmacy
Russian Federation, MoscowE. T. Zhilyakova
Belgorod State National Research University
Email: ezhilyakova@bsu.edu.ru
Dr.Sc. (Pharm.), Professor, Head of the Department of Pharmaceutical Technology
Russian Federation, BelgorodV. V. Chichulina
ITCT. M.V. Lomonosov, Russian Technological University
Email: murzilka991@gmail.com
Student, Department of Biotechnology and Industrial Pharmacy
Russian Federation, MoscowA. I. Gromakova
All-Russian Scientific Research Institute of Medicinal and Aromatic Plants
Email: a_gromakova@mail.ru
Dr.Sc. (Pharm.), Chief Research Scientist, the Scientific and Organizational Department
Russian Federation, MoscowV. N. Davydova
All-Russian Scientific Research Institute of Medicinal and Aromatic Plants
Email: davydova.vn@gmail.com
Dr.Sc. (Pharm.), Chief Research Scientist
Russian Federation, MoscowN. V. Sahno
Oryol state agrarian University named after N.V. Parakhina
Email: sahnoorelsau@mail.ru
Dr.Sc. (Veterinary), Professor of the Department Epizootology and therapy
Russian Federation, OryolReferences
- Astrafarm. Jelektronnyj resurs: http://www.astra-farm.ru/ katalog.htm (Data obrashhenija – 10.04.2021).
- Бырько В.М. Дитиокарбаматы Электронный ресурс: https://www.studmed.ru/byrko-v-m-ditiokarbamaty_4b9d51d56 65.html (Data obrashhenija – 11.05.2021).
- Grushko Ja.M. Vrednye organicheskie soedinenija v promyshlennyh vybrosah v atmosferu. Jelektronnyj resurs: https://www.airsoft-bit.ru/pervichnye-pokazateli-opas-nosti/347-grushko-vrednie-orgsordinenia-v-prom-stochnix-vodax-1982 (Data obrashhenija – 22.02.2022).
- Guzhova S.V., Simonova N.N., Liakumovich A.G., Sharafutdinova D.R., Holin K.V., Fatkullina A.F. Sanitarno-himicheskie issledovanija mnogokomponentnogo sostava veshhestv, migrirujushhih iz rezinovyh medicinskih probok na osnove butilkauchukov. Vestnik Roszdravnadzora. 2013; 5: 44-49.
- Guzhova S.V. Termojelastoplastichnyj material dlja probok farmacevticheskogo naznachenija: Avtoref. diss. kand. tehnicheskih nauk. Kazan', 2017. 20.
- Seljutin O.A. Razrabotka original'noj metodiki opredelenija serougleroda v infuzionnyh lekarstvennyh preparatah. Nauchnye rezul'taty biomedicinskih issledovanij. 2018; 4 (1): 88-98.
- Federal'nyj zakon «Ob obrashhenii lekarstvennyh sredstv» ot 12.04.2010 N 61-FZ.
- Gosudarstvennaja farmakopeja XIV. OFS.1.1.0012.15 Validacija analiticheskih metodik.