zhpsЖурнал прикладной спектроскопииZhurnal Prikladnoii Spektroskopii0514-7506B. I. Stepanov Institute of Physics of the National Academy of Scienceszhps-2428Research ArticleАННОТАЦИИ АНГЛОЯЗЫЧНЫХ СТАТЕЙABSTRACTS ENGLISH-LANGUAGE ARTICLESРазработка аналитических методов с использованием УФ-спектроскопии и принципов “зеленой” химии для оценки стабильности бензоата ризатриптанаStability Indicating UV Spectroscopy of Rizatriptan Benzoate by QbD Approach and Green Chemistry Principles: Sustainable Analytical Method DevelopmentPatkarA.PatkarAmit

Басван-Кудачи, Белагави, Карнатака

Basvan-Kudachi, Belagavi, Karnataka

MasareddyR.MasareddyRajashree

Басван-Кудачи, Белагави, Карнатака

Basvan-Kudachi, Belagavi, Karnataka

rajashreemasareddy@klepharma.eduJadhavS.JadhavShourya

Басван-Кудачи, Белагави, Карнатака

Basvan-Kudachi, Belagavi, Karnataka

Фармацевтический колледж KLE, Академия высшего образования и исследований KLEИндияDepartment of Pharmaceutics, KLE College of Pharmacy, Belagavi, KLE Academy of Higher Education and ResearchIndia202628092026935731731Copyright © Patkar A., Masareddy R., Jadhav S., 20262026Patkar A., Masareddy R., Jadhav S.Patkar A., Masareddy R., Jadhav S.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://zhps.ejournal.by/jour/article/view/2428

Разработаны спектрофотометрические методы количественного определения бензоата ризатриптана с использованием подхода QbD (Quality by Design). Спектрофотометрическое определение проводилось в диапазоне 200–400 нм. Разработанный метод валидирован в соответствии с рекомендациями ICH. Точность метода оценивалась путем расчета процентного относительного стандартного отклонения (%RSD). Полученные значения %RSD находятся в допустимых пределах, установленных нормативными документами, что подтверждает удовлетворительную точность и надежность метода для рутинных аналитических применений. Правильность метода оценивалась и выражалась в процентах среднего восстановления, экологичность оценена с использованием индекса экологической аналитической процедуры (GAPI), индекса применимости (BAGI) и инструмента AGREE. Метод валидирован в соответствии с рекомендациями Международного совета по гармонизации (ICH). Параметры валидации продемонстрировали удовлетворительные рабочие характеристики. Предложенный метод успешно применен для количественного анализа ризатриптана бензоата.

The present study describes the development and validation of QbD-assisted UV-Visible spectrophotometric methods for the quantitative determination of rizatriptan benzoate. The spectrophotometric determination was performed between 200–400 nm and the absorbance was compared to the wavelength. The developed method was validated according to the ICH guidelines for specificity, linearity, precision, accuracy, ruggedness, robustness, repeatability, forced degradation studies, and greenness assessment. The precision of the developed method was evaluated by calculating the percentage relative standard deviation (%RSD). The obtained %RSD values were within the acceptable limits specified by regulatory guidelines, confirming the method’s satisfactory precision and reliability for routine analytical applications. The accuracy of the developed method was evaluated and expressed as the percentage mean recovery which demonstrates the closeness of agreement between the measured and true values. The greenness of the developed UV spectroscopic method was evaluated using the Green analytical procedure index (GAPI), Blue applicability grade index (BAGI) and the AGREE tool, confirming compliance with green analytical chemistry principles. The method was developed and validated in accordance with the International Council for Harmonisation (ICH) guidelines for pharmaceuticals for human use. The validation parameters demonstrated satisfactory performance characteristics. The proposed method was successfully applied to the quantitative analysis of rizatriptan benzoate.

подход Quality by Design (QbD)ризатриптан бензоатиндекс GAPIиндекс BAGIМеждународный совет по гармонизации (ICH)quality by design (QbD)rizatriptan benzoategreen analytical procedure indexblue applicability grade indexInternational Council for Harmonization (ICH)We thank Cipla Pharmaceuticals Pvt. Ltd. (India) for providing pure rizatriptan benzoate. We are thankful to the Department of Pharmaceutics, KLE College of Pharmacy, Belagavi for providing research facilities and guidance.References. A. Borkowska, A. Kiełb, A. Mich, A. Kaźmierczak, P. Sornek, W. Izdebska, I. Pawlak, R. Ciesielski, J. Stanek, K. Perkowska, Qual. Sport, 37, 56600 (2025), https://doi.org/10.12775/QS.2025.37.56600.. A. Borkowska, A. Kiełb, A. Mich, A. Kaźmierczak, P. Sornek, W. Izdebska, I. Pawlak, R. Ciesielski, J. Stanek, K. Perkowska, Qual. Sport, 37, 56600 (2025), https://doi.org/10.12775/QS.2025.37.56600.F. Puledda, E. M. Silva, K. Suwanlaong, P. J. Goadsby, J. Neurol., 270, No. 7, 3654–3666 (2023), https://doi.org/10.1007/s00415-023-11706-1.F. Puledda, E. M. Silva, K. Suwanlaong, P. J. Goadsby, J. Neurol., 270, No. 7, 3654–3666 (2023), https://doi.org/10.1007/s00415-023-11706-1.N. Karsan, Continuum: Lifelong Learning in Neurology, 30, No. 2, 325–343 (2024), https://doi.org/10.1212/CON.0000000000001412.N. Karsan, Continuum: Lifelong Learning in Neurology, 30, No. 2, 325–343 (2024), https://doi.org/10.1212/CON.0000000000001412.R. B. Lipton, A. Gendolla, L. Abraham, A. Jenkins, J. Telfort, K. H. Blakeman, P. A. Saccone, I. Pustulka, I. Fotheringham, A. Engh, Headache, 65, No. 1, 164–179 (2025), https://doi.org/10.1111/head.14854.R. B. Lipton, A. Gendolla, L. Abraham, A. Jenkins, J. Telfort, K. H. Blakeman, P. A. Saccone, I. Pustulka, I. Fotheringham, A. Engh, Headache, 65, No. 1, 164–179 (2025), https://doi.org/10.1111/head.14854.S. Subalakshmi, R. Rushendran, C. Vellapandian, J. Neuroimmune Pharmacol., 20, No. 1, 30 (2025), https://doi.org/10.1007/s11481-025-10197-3.S. Subalakshmi, R. Rushendran, C. Vellapandian, J. Neuroimmune Pharmacol., 20, No. 1, 30 (2025), https://doi.org/10.1007/s11481-025-10197-3.N. Sudharshan, V. Swetha, Int. J. All Res. Educ. Sci. Methods, 12, No. 1, 1501–1507 (2023), https://doi.org/10.20959/wjpr202319-30171.N. Sudharshan, V. Swetha, Int. J. All Res. Educ. Sci. Methods, 12, No. 1, 1501–1507 (2023), https://doi.org/10.20959/wjpr202319-30171.R. Pawar, J. Drug Delivery and Biotherapeutics, 1, No. 2, 35–47 (2024), https://doi.org/10.61920/jddb.v1i02.147.R. Pawar, J. Drug Delivery and Biotherapeutics, 1, No. 2, 35–47 (2024), https://doi.org/10.61920/jddb.v1i02.147.G. Wejnerowska, I. Narloch, Analytica, 4, No. 4, 447–455 (2023), https://doi.org/10.3390/analytica4040032.G. Wejnerowska, I. Narloch, Analytica, 4, No. 4, 447–455 (2023), https://doi.org/10.3390/analytica4040032.A. Tayde, J. Drug Deliv. Biother., 1, No. 2, 13–23 (2024), https://doi.org/10.61920/jddb.v1i02.145.A. Tayde, J. Drug Deliv. Biother., 1, No. 2, 13–23 (2024), https://doi.org/10.61920/jddb.v1i02.145.S. F. Hammad, M. A. Hamid, L. Adly, S. H. Elagamy, Green Anal. Chem., 12, 100209 (2025), https://doi.org/10.1016/j.greeac.2025.100209.S. F. Hammad, M. A. Hamid, L. Adly, S. H. Elagamy, Green Anal. Chem., 12, 100209 (2025), https://doi.org/10.1016/j.greeac.2025.100209.D. Vachhani, J. H. Parekh, S. Patra, H. L. Varu, M. Soni, H. J. Jebaliya, J. Appl. Spectrosc., 91, No. 5, 1133–1140 (2024). https://doi.org/10.1007/s10812-024-01830-9.D. Vachhani, J. H. Parekh, S. Patra, H. L. Varu, M. Soni, H. J. Jebaliya, J. Appl. Spectrosc., 91, No. 5, 1133–1140 (2024). https://doi.org/10.1007/s10812-024-01830-9.A. C. Umarani, A. K. Patil, M. B. Karadesai, P. N. Mandi, S. B. Patil, S. S. Jalalpure, Anal. Chem. Lett., 15, No. 1, 103–118 (2025), https://doi.org/10.1080/22297928.2024.2416480.A. C. Umarani, A. K. Patil, M. B. Karadesai, P. N. Mandi, S. B. Patil, S. S. Jalalpure, Anal. Chem. Lett., 15, No. 1, 103–118 (2025), https://doi.org/10.1080/22297928.2024.2416480.M. A. Haque, V. Bakshi, M. Thippani, R. M. Manda, N. Boggula, J. Adv. Sci. Res., 12, No. 3, 113–119 (2021), https://doi.org/10.55218/JASR.s1202112313.M. A. Haque, V. Bakshi, M. Thippani, R. M. Manda, N. Boggula, J. Adv. Sci. Res., 12, No. 3, 113–119 (2021), https://doi.org/10.55218/JASR.s1202112313.M. K. Deka, A. Ansary, T. K. Das, A. K. Das, B. J. Sahariah, M. Majumder, Green Anal. Chem., 8, 100088 (2024), https://doi.org/10.1016/j.greeac.2023.100088.M. K. Deka, A. Ansary, T. K. Das, A. K. Das, B. J. Sahariah, M. Majumder, Green Anal. Chem., 8, 100088 (2024), https://doi.org/10.1016/j.greeac.2023.100088.R. El Sheikh, W. S. Hassan, A. A. Gouda, A. A. Al Owairdhi, Res. J. Pharm. Technol., 12, No. 5, 2123– 2130 (2019), https://doi.org/10.5958/0974-360X.2019.00352.4.R. El Sheikh, W. S. Hassan, A. A. Gouda, A. A. Al Owairdhi, Res. J. Pharm. Technol., 12, No. 5, 2123– 2130 (2019), https://doi.org/10.5958/0974-360X.2019.00352.4.L. Rani, A. K. Mishra, H. K. Dewangan, P. K. Sahoo, Lett. Drug Des. Discovery, 21, 2958–2966 (2024), https://doi.org/10.2174/0115701808252124231010055104.L. Rani, A. K. Mishra, H. K. Dewangan, P. K. Sahoo, Lett. Drug Des. Discovery, 21, 2958–2966 (2024), https://doi.org/10.2174/0115701808252124231010055104.S. Venkataraman, M. Manasa, Drug Invent. Today, 10, No. 2 (2018).S. Venkataraman, M. Manasa, Drug Invent. Today, 10, No. 2 (2018).N. Manousi, W. Wojnowski, J. Płotka-Wasylka, V. Samanidou, Green Chem., 25, No. 19, 7598–7604 (2023), https://doi.org/10.1039/D3GC02347H.N. Manousi, W. Wojnowski, J. Płotka-Wasylka, V. Samanidou, Green Chem., 25, No. 19, 7598–7604 (2023), https://doi.org/10.1039/D3GC02347H.

The authors declare that there are no conflicts of interest present.