Validation of the methods of quantitative analysis of ascorbic acid and rutoside in chewing lozenges
- Authors: Ismailov P.A.1, Inkin A.D.1, Krishtanova N.A.1, Sakanyan E.I.2
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Affiliations:
- Saint Petersburg State Chemical Pharmaceutical University
- Microgen
- Issue: Vol 28, No 5 (2025)
- Pages: 32-42
- Section: Articles
- URL: https://journals.eco-vector.com/1560-9596/article/view/687952
- DOI: https://doi.org/10.29296/25877313-2025-07-04
- ID: 687952
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Abstract
Introduction. Chewable lozenges are a relatively new dosage form with advantages such as ease of use, high bioavailability of active ingredients and the ability to control dosage. The development of new compositions with vitamins and vitamin-like substances is an urgent task, for which it is necessary to have validated methods for analyzing their quality. For the composition of lozenges with ascorbic acid and rutoside, titrimetric methods and spectrophotometry have been proposed.
The purpose of the work is to validate methods for the quantitative determination of ascorbic acid and rutoside in chewable lozenges intended for use as therapeutic and preventive vitamin products.
Material and methods. The developed methods for the quantitative determination of ascorbic acid and rutoside in chewing lozenges were validated according to the following indicators: specificity, linearity, analytical range, accuracy and precision (repeatability and intra-laboratory precision) in accordance with the requirements of the GPM.1.1.0012 "Validation of analytical methods" of the State Pharmacopoeia of the Russian Federation XV edition.
Results. Based on the conducted validation, it was confirmed that all applied methods meet the necessary acceptance criteria, which guarantees the reliability and accuracy of the results of quantitative determination of ascorbic acid and rutoside in chewable lozenges.
Conclusions. As a result of the conducted research, it was found that the spectrophotometric determination of rutoside in chewing lozenges is optimally carried out at a wavelength of 360 nm; ascorbic acid by iodometry (basic) and iodometry (alternative). The obtained data will be used in the development of regulatory documentation for the vitamin product.
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About the authors
P. A. Ismailov
Saint Petersburg State Chemical Pharmaceutical University
Author for correspondence.
Email: pasha.ismajlov@spcpu.ru
ORCID iD: 0009-0000-3981-9732
Student, Department of Pharmaceutical Chemistry
Russian Federation, 14 Professor Popova Street, lit. A, Aptekarsky Ostrov Municipal District, St. Petersburg, 197022A. D. Inkin
Saint Petersburg State Chemical Pharmaceutical University
Email: aleksandr.inkin@spcpu.ru
ORCID iD: 0009-0006-5166-8379
SPIN-code: 7685-5418
Post-graduate Student, Department of Pharmaceutical Chemistry
Russian Federation, 14 Professor Popova Street, lit. A, Aptekarsky Ostrov Municipal District, St. Petersburg, 197022N. A. Krishtanova
Saint Petersburg State Chemical Pharmaceutical University
Email: nadezhda.krishtanova@pharminnotech.com
ORCID iD: 0000-0002-4761-2077
SPIN-code: 4395-8012
Ph.D. (Pharm.), Associate Professor, Department of Pharmaceutical Chemistry
Russian Federation, 14 Professor Popova Street, lit. A, Aptekarsky Ostrov Municipal District, St. Petersburg, 197022E. I. Sakanyan
Microgen
Email: pasha.ismajlov@spcpu.ru
ORCID iD: 0000-0002-1693-2422
SPIN-code: 8050-4040
Dr.Sc. (Pharm.), Professor, Director of Science
Russian Federation, 10, the 2nd Volkonsky lane, Moscow, 127473References
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