Development and validation of a methodology for the quantitative determination of vitamin D3 in tablets

Author:

Gutnova T.S.1,Kompantsev D.V.2,Kisieva M.T.1,Potupchik T.V.3

Affiliation:

1. Federal State Budgetary Educational Institution of Higher Education "North Ossetian State Medical Academy", Pushkinskaya str., 40, Vladikavkaz, 362019, Russian Federation

2. Pyatigorsk Medical and Pharmaceutical Institute is a branch of the Federal State budgetary educational Institution of Higher Education "Volgograd State Medical University", Kalinin Ave., 11, Pyatigorsk, 357532, Russian Federation

3. 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, Partizana Zheleznyaka str., 1, Krasnoyarsk, 660022, Russian Federation

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.

Publisher

Russian Vrach, Publishing House Ltd.

Reference21 articles.

1. Carmeliet G., Dermauw V., Bouillon R. Vitamin D signaling in calcium and bone homeostasis: A delicate balance. Best Practice & Research Clinical Endocrinology & Metabolism. 2015; 29 (4): 621–31. DOI: 10.1016/j.beem. 2015.06.001.

2. Dawson-Hughes B. The role of calcium in bone growth and preservation. World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO 2017): Non-sponsored Symposia Abstracts. Osteoporos Int. 2017; 28 (S1): 99–126. DOI: 10.1007/s00198-017-3943-1.

3. Harmon Q.E. Use of Estrogen – Containing Contraception Is Associated With Increased Concentrations of 25 – Hydroxy Vitamin D. Q. E. Harmon, D. M. Umbach, D. D. Baird. J. Clin. Endocrinol. Metab. 2016; 101 (9): 3370–7.

4. Громова О.А., Торшин И.Ю., Гришина Т.Р., Малявская С.И. О ролях витамина D в профилактике и терапии мужского бесплодия. Качественная клиническая практика. 2017; 3: 61–71. [Gromova O.A., Torshin I.Yu., Grishina T.R., Malyavskaya S.I. O roljah vitamina D v profilaktike i terapii muzhskogo besplodija. Kachestvennaya klinicheskaya praktika. 2017; 3: 61–71 (In Russian)].

5. Добровольская О.В., Тропцова Н.В. Клиническая практика: место препаратов кальция и витамина D в лечении остеопороза. Лечащий врач. 2021; 4: 26–30. DOI: 10.51793/OS.2021.51.40.005 [Dobrovol`skaya O.V., Tropczova N.V. Klinicheskaja praktika: mesto preparatov kal'cija i vitamina D v lechenii osteoporoza. Lechashhij vrach. 2021; 4: 26–30. DOI: 10.51793/OS.2021.51.40.005 (In Russian)].

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3