zhpsЖурнал прикладной спектроскопииZhurnal Prikladnoii Spektroskopii0514-7506B. I. Stepanov Institute of Physics of the National Academy of Scienceszhps-2357Research ArticleАННОТАЦИИ АНГЛОЯЗЫЧНЫХ СТАТЕЙABSTRACTS ENGLISH-LANGUAGE ARTICLESЭкологически чистый УФ-спектроскопический метод количественного определения ванилиновой кислоты в нерасфасованном виде и нанопрепаратахNovel Green and QbD-Assisted UV Spectroscopic Method for Vanillic Acid Quantification in Bulk and NanoformulationNagaprajwalA. A.NagaprajwalA. A.

KAHER, Белагави 

KAHER, Belagavi 

SutarK. P.SutarK. P.

KAHER, Белагави 

KAHER, Belagavi 

kishorisutar@klepharm.eduLadA. M.LadA. M.

KAHER, Белагави 

KAHER, Belagavi 

Фармацевтический колледж KLEИндияKLE College of PharmacyIndia20260809202693457611Copyright © Nagaprajwal A., Sutar K., Lad A., 20262026Nagaprajwal A., Sutar K., Lad A.Nagaprajwal A., Sutar K., Lad A.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/2357

Разработан и валидирован УФ-спектрофотометрический метод количественного определения ванилиновой кислоты в субстанции и ниосомальных препаратах в рамках концепции “качество через проектирование” (QbD). Фосфатный буфер (pH 6.8) использован в качестве экологически чистого растворителя в соответствии с принципами “зеленой” аналитической химии. Ключевые аналитические переменные (время ультразвуковой обработки и интервал сканирования) оптимизированы с использованием подхода планирования экспериментов для повышения точности и надежности. Оптимизированный метод показал максимальное поглощение при 251 нм с линейностью в диапазоне концентраций 2—16 мкг/мл (R2 = 0.999). Валидация в соответствии с рекомендациями ICH Q2(R1) продемонстрировала высокую точность (степень извлечения 99.65—101.41%), прецизионность (относительное стандартное отклонение <2%), чувствительность (предел обнаружения 0.229 мкг/мл; предел количественного определения 0.694 мкг/мл) и устойчивость в различных условиях. Исследования принудительной деградации в кислой, щелочной, окислительной и фотолитической средах подтвердили стабильность метода. Разработанный метод успешно применен для количественного определения ниосомальных препаратов, содержащих витамин А, с эффективностью инкапсуляции 82.76%. Оценка экологичности (AGREE = 0.82; AGREEprep = 0.80) подтвердила устойчивость метода. Метод можно использовать для рутинного количественного определения витамина А в чистом виде и в нанопрепаратах.

A green, stability-indicating UV-spectrophotometric method was developed and validated for the quantification of vanillic acid (VA) in bulk and niosomal formulations within a Quality by Design (QbD) framework. This method utilises a phosphate buffer (pH 6.8) as an eco-friendly solvent, in accordance with the principles of green analytical chemistry. Key analytical variables, such as sonication time and scanning interval, were optimized using a Design of Experiments (DoE) approach to enhance precision and robustness. The optimized method exhibited a maximum absorbance at 251 nm with excellent linearity over a concentration range of 2–16 µg/mL (R2 = 0.999). Validation according to the ICH Q2(R1) guidelines demonstrated high accuracy (recoveries between 99.65–101.41%), precision (RSD < 2%), sensitivity (LOD = 0.229 µg/mL; LOQ = 0.694 µg/mL), and robustness under variable conditions. Forced degradation studies in acidic, basic, oxidative, and photolytic environments confirmed the stability of the method. The developed method was successfully applied to quantify VA-loaded niosomal formulations, yielding an entrapment efficiency of 82.76%. Greenness assessments (AGREE = 0.82; AGREE prep = 0.80) confirmed the sustainability of the method. Overall, this study establishes a novel, green, and QbD-driven analytical approach that offers reliability, regulatory compliance, and environmental responsibility for the routine quantification of VA in bulk and nanoformulations.

УФ-спектрофотометрияванилиновая кислотаконцепция “качество через проектирование” QbD“зеленая” аналитическая химияниосомаUV spectrophotometryvanillic acidquality by designgreen analytical chemistryniosomeReferencesX. Zhang, H. Fan, S. Han, T. Zhang, Y. Sun, L. Yang, W. Li, BMC Gastroenterology, 25, No. 1, 332 (2025), https://doi.org/10.1186/s12876-025-03948-2.X. Zhang, H. Fan, S. Han, T. Zhang, Y. Sun, L. Yang, W. Li, BMC Gastroenterology, 25, No. 1, 332 (2025), https://doi.org/10.1186/s12876-025-03948-2.A. Dey, A. Mitra, S. Pathak, S. Prasad, A. S. Zhang, H. Zhang, X. F. Sun, A. Banerjee, Technol. Cancer Res. Treatment., 22 (2023), https://doi.org/10.1177/15330338231178403.A. Dey, A. Mitra, S. Pathak, S. Prasad, A. S. Zhang, H. Zhang, X. F. Sun, A. Banerjee, Technol. Cancer Res. Treatment., 22 (2023), https://doi.org/10.1177/15330338231178403.M. Olfatifar, F. Rafiei, A. Sadeghi, E. Ataei, M. A. Habibi, M. Pezeshgi Modarres, Z. Ghalavand, H. Houri, J. Epidemiology and Global Health, 15, No. 1, 5 (2025), https://doi.org/10.1007/s44197-025-00348-3.M. Olfatifar, F. Rafiei, A. Sadeghi, E. Ataei, M. A. Habibi, M. Pezeshgi Modarres, Z. Ghalavand, H. Houri, J. Epidemiology and Global Health, 15, No. 1, 5 (2025), https://doi.org/10.1007/s44197-025-00348-3.A. Ingole, M. P. Kadam, A. P. Dalu, S. M. Kute, P. R. Mange, V. D. Theng, O. R. Lahane, A. P. Nikas, Y. V. Kawal, S. U. Nagrik, P. A. Patil, J. Drug Deliv. Ther., 11, 200–204 (2021), http://dx.doi.org/10.22270/jddt.v11i2-s.4823.A. Ingole, M. P. Kadam, A. P. Dalu, S. M. Kute, P. R. Mange, V. D. Theng, O. R. Lahane, A. P. Nikas, Y. V. Kawal, S. U. Nagrik, P. A. Patil, J. Drug Deliv. Ther., 11, 200–204 (2021), http://dx.doi.org/10.22270/jddt.v11i2-s.4823.S. K. Velli, Int. J. Pharm. Pharm. Sci. (2020).S. K. Velli, Int. J. Pharm. Pharm. Sci. (2020).A. C. Mirza, S. S. Panchal, Turkish J. Pharm. Sci., 17, No. 4, 432 (2020), https://doi.org/10.4274/tjps.galenos.2019.92678.A. C. Mirza, S. S. Panchal, Turkish J. Pharm. Sci., 17, No. 4, 432 (2020), https://doi.org/10.4274/tjps.galenos.2019.92678.M. Matejczyk, P. Ofman, E. Juszczuk-Kubiak, R. Świsłocka, W. L. Shing, K. K. Kesari, B. Prakash, W. Lewandowski, Ecotoxicology and Environmental Safety, 277, 116383 (2024), https://doi.org/10.1016/j.ecoenv.2024.116383.M. Matejczyk, P. Ofman, E. Juszczuk-Kubiak, R. Świsłocka, W. L. Shing, K. K. Kesari, B. Prakash, W. Lewandowski, Ecotoxicology and Environmental Safety, 277, 116383 (2024), https://doi.org/10.1016/j.ecoenv.2024.116383.J. Kaur, M. Gulati, K. Gowthamarajan, S. Vishwas, D. K. Chellappan, G. Gupta, K. Dua, N. K. Pandey, B. Kumar, S. K. Singh, Med. Hypotheses, 156, 110679 (2021), https://doi.org/10.1016/j.mehy.2021.110679.J. Kaur, M. Gulati, K. Gowthamarajan, S. Vishwas, D. K. Chellappan, G. Gupta, K. Dua, N. K. Pandey, B. Kumar, S. K. Singh, Med. Hypotheses, 156, 110679 (2021), https://doi.org/10.1016/j.mehy.2021.110679.J. Kaur, M. Gulati, P. Famta, L. Corrie, A. Awasthi, S. Saini, G. L. Khatik, V. G. Bettada, S. V. Madhunapantula, K. R. Paudel, G. Gupta, Int. J. Pharm., 624, 121987 (2022), https://doi.org/10.1016/j.ijpharm.2022.121987.J. Kaur, M. Gulati, P. Famta, L. Corrie, A. Awasthi, S. Saini, G. L. Khatik, V. G. Bettada, S. V. Madhunapantula, K. R. Paudel, G. Gupta, Int. J. Pharm., 624, 121987 (2022), https://doi.org/10.1016/j.ijpharm.2022.121987.V. S. Patil, K. P. Sutar, R. D. Pockle, S. Usulkar, V. A. Jadhav, Therap. Delivery, 14, No. 10, 635–647 (2023), https://doi.org/10.4155/tde-2023-0059.V. S. Patil, K. P. Sutar, R. D. Pockle, S. Usulkar, V. A. Jadhav, Therap. Delivery, 14, No. 10, 635–647 (2023), https://doi.org/10.4155/tde-2023-0059.S. Kumari, A. Goyal, E. Sönmez Gürer, E. Algın Yapar, M. Garg, M. Sood, R. K. Sindhu, Pharmaceutics, 14, No. 5, 1091 (2022), https://doi.org/10.3390/pharmaceutics14051091.S. Kumari, A. Goyal, E. Sönmez Gürer, E. Algın Yapar, M. Garg, M. Sood, R. K. Sindhu, Pharmaceutics, 14, No. 5, 1091 (2022), https://doi.org/10.3390/pharmaceutics14051091.S. Javaid, T. Rana, Z. Naeem, N. Sajid, Currents in Pharm. Res., 2, No. 1, 1–34 (2024), https://doi.org/10.32350/cpr.21.01.S. Javaid, T. Rana, Z. Naeem, N. Sajid, Currents in Pharm. Res., 2, No. 1, 1–34 (2024), https://doi.org/10.32350/cpr.21.01.Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development, Eds. M. C. Breitkreitz, H. Goicoechea, Gewerbestrasse, Cham, Switzerland, Springer, 13 (2023), https://doi.org/10.1007/978-3-031-31505-3.Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development, Eds. M. C. Breitkreitz, H. Goicoechea, Gewerbestrasse, Cham, Switzerland, Springer, 13 (2023), https://doi.org/10.1007/978-3-031-31505-3.S. Sharma, S. Naman, K. Goyal, A. Baldi, Indian J. Pharm. Ed. Res., 57, No. 1, 250–263 (2023), https://doi.org/1010.5530/001954641318.S. Sharma, S. Naman, K. Goyal, A. Baldi, Indian J. Pharm. Ed. Res., 57, No. 1, 250–263 (2023), https://doi.org/1010.5530/001954641318.M. Zaripour, V. Zare-Shahabadi, H. J. Jahromi, Spectrochim. Acta, Part A: Mol. and Biomolec. Spectrosc., 222, 117197 (2019), https://doi.org/10.1016/j.saa.2019.117197.M. Zaripour, V. Zare-Shahabadi, H. J. Jahromi, Spectrochim. Acta, Part A: Mol. and Biomolec. Spectrosc., 222, 117197 (2019), https://doi.org/10.1016/j.saa.2019.117197.M. A. Krstonošić, J. C. Hogervorst, M. Mikulić, L. Gojković-Bukarica, Acta Chromatogr., 32, No. 2, 134–138 (2020), https://doi.org/10.1556/1326.2019.00611.M. A. Krstonošić, J. C. Hogervorst, M. Mikulić, L. Gojković-Bukarica, Acta Chromatogr., 32, No. 2, 134–138 (2020), https://doi.org/10.1556/1326.2019.00611.F. Al-Rimawi, I. Odeh, J. AOAC Int., 98, No. 5, 1335–1339 (2015), https://doi.org/10.5740/jaoacint.15-010.F. Al-Rimawi, I. Odeh, J. AOAC Int., 98, No. 5, 1335–1339 (2015), https://doi.org/10.5740/jaoacint.15-010.J. Shi, L. Peng, W. Chen, W. Qiao, K. Wang, Y. Xu, J. Cheng, Food Sci. & Nutrition, 12, No. 7, 5036–5051 (2024), https://doi.org/10.1002/fsn3.4154.J. Shi, L. Peng, W. Chen, W. Qiao, K. Wang, Y. Xu, J. Cheng, Food Sci. & Nutrition, 12, No. 7, 5036–5051 (2024), https://doi.org/10.1002/fsn3.4154.J. P. Oliveira, S. Gomes, K. C. Ladeira, L. C. Cameron, A. F. Macedo, M. G. Koblitz, Food Res. Int., 168, 112739 (2023), https://doi.org/10.1016/j.foodres.2023.112739.J. P. Oliveira, S. Gomes, K. C. Ladeira, L. C. Cameron, A. F. Macedo, M. G. Koblitz, Food Res. Int., 168, 112739 (2023), https://doi.org/10.1016/j.foodres.2023.112739.J. Gruz, O. Novák, M. Strnad, Food Chem., 111, No. 3, 789–794 (2008), https://doi.org/10.1016/j.foodchem.2008.05.014.J. Gruz, O. Novák, M. Strnad, Food Chem., 111, No. 3, 789–794 (2008), https://doi.org/10.1016/j.foodchem.2008.05.014.T. R. Rao, B. Srilaxmi, J. Drug Delivery & Therap., 15, No. 4 (2025), https://doi.org/10.22270/jddt.v15i4.7089.T. R. Rao, B. Srilaxmi, J. Drug Delivery & Therap., 15, No. 4 (2025), https://doi.org/10.22270/jddt.v15i4.7089.S. M. Miladinović, Anal. and Bioanal. Chem., 417, No. 4, 665–673 (2025), https://doi.org/10.1007/s00216-024-05680-4.S. M. Miladinović, Anal. and Bioanal. Chem., 417, No. 4, 665–673 (2025), https://doi.org/10.1007/s00216-024-05680-4.I. M. Fukuda, C. F. Pinto, C. D. Moreira, A. M. Saviano, F. R. Lourenço, Brazilian J. Pharm. Sci., 54, e01006 (2018), https://doi.org/10.1590/s2175-97902018000001006.I. M. Fukuda, C. F. Pinto, C. D. Moreira, A. M. Saviano, F. R. Lourenço, Brazilian J. Pharm. Sci., 54, e01006 (2018), https://doi.org/10.1590/s2175-97902018000001006.S. S. Panda, J. Rath, V. V. Ravi Kumar Bera, Anal. Chem. Lett., 8, No. 4, 510–518 (2018), https://doi.org/10.1080/22297928.2018.1446845.S. S. Panda, J. Rath, V. V. Ravi Kumar Bera, Anal. Chem. Lett., 8, No. 4, 510–518 (2018), https://doi.org/10.1080/22297928.2018.1446845.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.H. Vancha, D. Tewari, R. Kumar, P. Govindaiah, S. Mohd, S. K. Singh, M. Gulati, Turkish J. Pharm. Sci., 20, No. 3, 165 (2023), https://doi.org/10.4274/tjps.galenos.2022.05335.H. Vancha, D. Tewari, R. Kumar, P. Govindaiah, S. Mohd, S. K. Singh, M. Gulati, Turkish J. Pharm. Sci., 20, No. 3, 165 (2023), https://doi.org/10.4274/tjps.galenos.2022.05335.S. Hooli, K. P. Sutar, S. S. Sammasagi, M. K. Chouhan, Chromatographia, 21, 1–5 (2025), https://doi.org/10.1007/s10337-025-04427-2.S. Hooli, K. P. Sutar, S. S. Sammasagi, M. K. Chouhan, Chromatographia, 21, 1–5 (2025), https://doi.org/10.1007/s10337-025-04427-2.G. G. Patil, R. S. Bhave, P. S. Bobade, D. R. Telange, S. B. Ganorkar, A. A. Shirkedkar. J. Appl. Spectrosc., 92 (2025), https://doi.org/10.1007/s10812-025-01930-0.G. G. Patil, R. S. Bhave, P. S. Bobade, D. R. Telange, S. B. Ganorkar, A. A. Shirkedkar. J. Appl. Spectrosc., 92 (2025), https://doi.org/10.1007/s10812-025-01930-0.ICH guideline Q2 (R1). Validation of Analytical Procedures. Int. Conf. on Harmonization, IFPMA, Geneva (2003).ICH guideline Q2 (R1). Validation of Analytical Procedures. Int. Conf. on Harmonization, IFPMA, Geneva (2003).S. Sulakude, N. Shirkoli, Int. J. Pharm. Inv., 15, No. 2 (2025), https://doi.org/10.5530/ijpi.20250153.S. Sulakude, N. Shirkoli, Int. J. Pharm. Inv., 15, No. 2 (2025), https://doi.org/10.5530/ijpi.20250153.E. Aruna, K. B. Sri, M. Sumakanth, Asian J. Pharm. Res. and Development., 9, No. 4, 16–20 (2021). https://doi.org/10.22270/ajprd.v9i4.983.E. Aruna, K. B. Sri, M. Sumakanth, Asian J. Pharm. Res. and Development., 9, No. 4, 16–20 (2021). https://doi.org/10.22270/ajprd.v9i4.983.B. Kurangi, S. Jalalpure, Indian J. Pharm. Ed. Res., 54, 677–686 (2020), https://doi.org/10.5530/ijper.54.3s.168.B. Kurangi, S. Jalalpure, Indian J. Pharm. Ed. Res., 54, 677–686 (2020), https://doi.org/10.5530/ijper.54.3s.168.K. V. Jadhav, D. L. Dhamecha, G. P. Asnani, P. R. Patil, M. B. Patil, Pharm. Methods, 4, No. 1, 21–25 (2013), https://doi.org/10.1016/j.phme.2013.03.001.K. V. Jadhav, D. L. Dhamecha, G. P. Asnani, P. R. Patil, M. B. Patil, Pharm. Methods, 4, No. 1, 21–25 (2013), https://doi.org/10.1016/j.phme.2013.03.001.S. S. Chimagave, S. S. Jalalpure, A. K. Patil, B. K. Kurangi, Indian J. Pharm. Ed. Res., 56, No. 3, 865–872 (2022), https://doi.org/10.5530/ijper.56.3.139.S. S. Chimagave, S. S. Jalalpure, A. K. Patil, B. K. Kurangi, Indian J. Pharm. Ed. Res., 56, No. 3, 865–872 (2022), https://doi.org/10.5530/ijper.56.3.139.B. M. Do, N. T. Le, T. P. Nguyen, T. T. Pham, M. T. Le, M. H. Nguyen, Adv. Natural Sci.: Nanosci. and Nanotechnol., 16, No. 2, 025011 (2025), https://doi.org/10.1088/2043-6262/adc4c4.B. M. Do, N. T. Le, T. P. Nguyen, T. T. Pham, M. T. Le, M. H. Nguyen, Adv. Natural Sci.: Nanosci. and Nanotechnol., 16, No. 2, 025011 (2025), https://doi.org/10.1088/2043-6262/adc4c4.

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