Development and validation of a methodology for the quantitative determination of vitamin D3 in tablets
- Authors: Gutnova T.S.1, Kompantsev D.V.2, Kisieva M.T.1, Potupchik T.V.3
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Affiliations:
- Federal State Budgetary Educational Institution of Higher Education "North Ossetian State Medical Academy"
- Pyatigorsk Medical and Pharmaceutical Institute is a branch of the Federal State budgetary educational Institution of Higher Education "Volgograd State Medical University"
- Federal State Budgetary Educational Institution of Higher Education “Krasnoyarsk State Medical University named after Professor V.F. Voino-Yasenetsky” of the Ministry of Health of the Russian Federation
- Issue: Vol 73, No 3 (2024)
- Pages: 24-32
- Section: Pharmaceutical chemistry and pharmacognosy
- URL: https://journals.eco-vector.com/0367-3014/article/view/633223
- DOI: https://doi.org/10.29296/25419218-2024-03-04
- ID: 633223
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Abstract
Introduction. The active pharmaceutical substance of the tablets is vitamin D3 (cholecalciferol), therefore, quantitative analysis methods are being developed to determine it. The methodology given in the general pharmacopoeia article of the OFS was taken as a basis.1.2.3.0017.15 "Methods of quantitative determination of vitamins" of the State Pharmacopoeia of the Russian Federation XV edition. This article proposes a quantitative analysis of vitamin D3 using the method of high-performance liquid chromatography (HPLC).
Goal. Development and validation of a methodology for the quantitative determination of the active pharmaceutical substance vitamin D3 in tablets.
Material and methods. To develop and validate a method for the quantitative determination of vitamin D3 in tablets, a high-performance liquid chromatography method was used: chromatograph Chromosome A02 (Chromosome Engineering, Russia) equipped with an ECD2000 UV detector (ECOM, Czech Republic), a column Luna C18(2) 150×4.6 mm was used for separation. The analysis and validation characteristics were performed in accordance with the requirements of the State Pharmacopoeia of the Russian Federation XV edition.
Results. It was found that during HPLC analysis, the average content of cholecalciferol in the drug was 126.2±3 micrograms/ml (100.9% of the declared value; the relative error of determination was ±2.38%). A validation assessment of the proposed technique was carried out in terms of specificity, linearity, precision (level of convergence), which confirmed its suitability for authenticating and quantifying cholecalciferol in a medicinal product.
Conclusion. The results obtained indicate the possibility of using the method of high-performance liquid chromatography in the isocratic mode for the quantitative determination of the active pharmaceutical substance vitamin D3 in tablets coated with an intestinal soluble shell for the treatment and prevention of vitamin D-dependent nosologies.
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About the authors
Taisiya Skandarbekovna Gutnova
Federal State Budgetary Educational Institution of Higher Education "North Ossetian State Medical Academy"
Author for correspondence.
Email: tgutnova@mail.ru
ORCID iD: 0000-0003-2079-7304
Senior Laboratory Assistant at the Department of Pharmacy
Russian Federation, VladikavkazDmitry Vladislavovich Kompantsev
Pyatigorsk Medical and Pharmaceutical Institute is a branch of the Federal State budgetary educational Institution of Higher Education "Volgograd State Medical University"
Email: farmacontractp@bk.ru
ORCID iD: 0000-0002-2152-0270
Doctor of Pharmaceutical Sciences, Head of the Department of Pharmaceutical Technology with a Course in Medical Biotechnology
Russian Federation, PyatigorskManana Tengizovna Kisieva
Federal State Budgetary Educational Institution of Higher Education "North Ossetian State Medical Academy"
Email: mananakisieva@mail.ru
ORCID iD: 0000-0002-0960-0980
Candidate of Pharmaceutical Sciences, Associate Professor of the Department of Pharmacy
Russian Federation, VladikavkazTatyana Vitalievna Potupchik
Federal State Budgetary Educational Institution of Higher Education “Krasnoyarsk State Medical University named after Professor V.F. Voino-Yasenetsky” of the Ministry of Health of the Russian Federation
Email: potupchik_tatyana@mail.ru
ORCID iD: 0000-0003-1133-4447
Candidate of Medical Sciences, Associate Professor of the Department of Pharmacology with Clinical Pharmacology
Russian Federation, KrasnoyarskReferences
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