Development and validation method for quantitative determination taurine and allantoin in chitosan gel by high performance liquid chromatography

  • Pavel A. Fedosov AstraZeneca Pharmaceuticals LLC, Moscow
  • Svetlana I. Vasilyeva Voronezh State University, Voronezh
  • Vladislav G. Frolov Сharles university, Hradec Kralove, Czech Republic
  • Alexey I. Slivkin Voronezh State University, Voronezh
  • Elena V. Vorfolomeeva Moscow State University of Fine Chemical Technologies, Moscow
  • Aliona S. Belenova Voronezh State University, Voronezh
  • Anna A. Kulakova Voronezh Institute of the Ministry of internal Affairs Russian Federation, Voronezh
  • Kenzhebek Sh. Urazgaliyev West Kazakhstan Medical University named after Marat Ospanov, Aktobe
Keywords: validation, taurine, allantoin, chitosan, HPLC.

Abstract

The subject of the article is the development and validation of a technique for the quantitative determination of taurine and allantoin in the combined presence of chitazan gel, by high-performance liquid chromatography with UV detection. The aim of the work was to develop and validate a technique for the quantitative determination of taurine and allantoin in a chitosan-based gel by HPLC, taking into account sample preparation. The quantitative determination of the gel components was developed taking into account individual sample preparation for each of the active substances and includes the manufacture of two mobile phases for the determination of taurine and allantoin, respectively. The methodology was validated according to the following indicators: specificity, linearity, correctness and precision. The specificity was confirmed by the absence of peaks with retention time of taurine and allantoin in the solvent for sample preparation.

Linearity was confirmed for the analytical region of taurine and allantoin, after constructing a calibration graph and finding the correlation coefficient. Accuracy and precision. To establish the correctness, nine samples were analyzed at three concentration levels for each sample preparation. The accuracy of the technique was determined by the openability index and the value of the response factor. Results of the work: The specificity of the methodology has been established. Linearity was confirmed after establishing the correlation coefficient (r) for taurine 0.9994, for allantoin 0.9995.Correctness and precision were confirmed by the presence of a response factor in the range of 99<R<101%. The data obtained indicate that the technique provides reliable and reproducible results.

Thus, the technique can be used to assess the quantitative content of taurine and allantoin in combined medicines related to elastic-visco-plastic dosage forms similar to a gel with taurine and allantoin based on chitosan. The developed method provides reproducible and accurate results, which allows it to be used to determine the quantitative content of taurine and allantoin at the stages of gel production, and to assess the quality of the gel.

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Author Biographies

Pavel A. Fedosov, AstraZeneca Pharmaceuticals LLC, Moscow

Medical Science Liaison, AstraZeneca Pharmaceuticals LLC, Candidate of Pharmaceutical Sciences, Moscow, Russia, e-mail: Fedosov91@gmail.com

Svetlana I. Vasilyeva, Voronezh State University, Voronezh

Associate Professor of the Department of Pharmaceutical Chemistry and Pharmaceutical Technology, Candidate of Pharmaceutical Sciences, Associate Professor, Voronezh State University, Voronezh, Russia, e-mail: provotorova-svetlana@mail.ru

Vladislav G. Frolov, Сharles university, Hradec Kralove, Czech Republic

graduate student, Сharles university, Hradec Kralove, Czech Republic, e-mail: vlad_frol@inbox.ru

Alexey I. Slivkin, Voronezh State University, Voronezh

Head of the Department of Pharmaceutical Chemistry and Pharmaceutical Technology, doctor of pharmaceutical Sciences, Professor, Voronezh state University, Voronezh, Russia

Elena V. Vorfolomeeva, Moscow State University of Fine Chemical Technologies, Moscow

Senior Lecturer of MAREA RTU, Candidate of Pharmaceutical Sciences, MEREA RTU, Moscow, Russia, e-mail: vorfolomeevae.v@yandex.ru

Aliona S. Belenova, Voronezh State University, Voronezh

Associate Professor of the Department of Pharmaceutical Chemistry and Pharmaceutical Technology, Candidate of Biological Sciences, Voronezh State University, Voronezh, Russia, e-mail: belenova@pharm.vsu.ru

Anna A. Kulakova, Voronezh Institute of the Ministry of internal Affairs Russian Federation, Voronezh

Senior lecturer at the Department of Tactical and Special Training, Lieutenant Colonel of Police, Candidate of Medical Sciences, VI Ministry of Internal Affairs of Russia, Voronezh, Russia, e-mail: mschkulakova@yandex.ru

Kenzhebek Sh. Urazgaliyev, West Kazakhstan Medical University named after Marat Ospanov, Aktobe

Senior Lecturer at the Department of Pharmaceutical Disciplines, Candidate of Biological Sciences, Faculty Pharmacy Advisor, West Kazakhstan Medical University named after Marat Ospanov, Republic of Kazakhstan, Aktobe city, e-mail: svet.tolga@mail.ru

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Published
2025-04-04
How to Cite
Fedosov, P. A., Vasilyeva, S. I., Frolov, V. G., Slivkin, A. I., Vorfolomeeva, E. V., Belenova, A. S., Kulakova, A. A., & Urazgaliyev, K. S. (2025). Development and validation method for quantitative determination taurine and allantoin in chitosan gel by high performance liquid chromatography. Sorbtsionnye I Khromatograficheskie Protsessy, 25(1), 17-25. https://doi.org/10.17308/sorpchrom.2025.25/12789