zhpsЖурнал прикладной спектроскопииZhurnal Prikladnoii Spektroskopii0514-7506B. I. Stepanov Institute of Physics of the National Academy of Scienceszhps-2425Research ArticleАННОТАЦИИ АНГЛОЯЗЫЧНЫХ СТАТЕЙABSTRACTS ENGLISH-LANGUAGE ARTICLESРазработка и валидация метода спектрофотометрии в УФвидимом диапазоне для количественного определения катехингидрата в нерасфасованном виде с использованием этанола в качестве экологически безопасного растворителяDevelopment and Validation of an Eco-Friendly UV-Visible Spectrophotometric Method for Quantitative Estimation of Catechin Hydrate in Bulk Using Ethanol as a Green Solvent: a Sustainable Approach for Low-Income Country SettingsSinghA.SinghAstha

Уттар-Прадеш, Нойда,  Уттар-Прадеш

Noida, U.P.

singhastha321@gmail.comRaiS. N.RaiSomesh Narayan

Уттар-Прадеш, Нойда,  Уттар-Прадеш

Noida, U.P.

raisomesh0@gmail.comNagpalK.NagpalKalpana

Уттар-Прадеш, Нойда,  Уттар-Прадеш

Noida, U.P.

kalpananagpal@gmail.comФармацевтический институт Амити, Университет АмитиИндияAmity Institute of Pharmacy, Amity University Uttar PradeshIndia202628092026935728728Copyright © Singh A., Rai S., Nagpal K., 20262026Singh A., Rai S., Nagpal K.Singh A., Rai S., Nagpal K.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/2425

 

Разработан и валидирован эффективный экологичный метод спектрофотометрии в УФ-видимом диапазоне для количественного определения катехингидрата в чистом виде с использованием водного раствора этанола 0.01% (об./об.). Метод валидирован в соответствии с рекомендациями ICH. Установлено, что метод обладает хорошей линейностью в диапазоне 2–20 мкг/мл с R2 = 0.9976 и λmax = 278 нм. Высокая точность метода подтверждена с помощью экспериментов по определению степени извлечения, которая варьирует от 99.39 до 99.48%. Прецизионность метода обеспечена приемлемым относительным стандартным отклонением (%RSD). LOD и LOQ для катехингидрата 0.523 и 1.585 мкг/мл. Растворимость катехингидрата в исследуемой системе растворителей 114.631 мкг/мл. С точки зрения экологии общая устойчивость данного метода, измеренная с помощью инструмента Analytical Greenness (AGREE), составила 0.84, что в значительной степени соответствует принципам “зеленой” аналитической химии. Предложенный метод подходит для рутинного анализа контроля качества фармацевтических и нутрицевтических препаратов.

A cost-effective, environmentally friendly UV-visible spectrophotometric method for the quantitative determination of catechin hydrate in pure form using hydroalcoholic solution of 0.01% (v/v) ethanol has been developed and validated. The aim of the study was to develop a sustainable analytical instrument for use in quality control purposes in resource-poor environments. The method was validated as per ICH guidelines, and different validation parameters such as linearity, accuracy, precision, sensitivity, and robustness were investigated. It is found that the method possesses good linearity over the range of 2–20 µg/mL with R2 = 0.9976 and λmax = 278 nm. Good accuracy of the method was obtained by means of recovery experiments, as percentage recovery values varied between 99.39 and 99.48%. Precision of the method was ensured through an acceptable percentage relative standard deviation (%RSD). The LOD and LOQ values for catechin hydrate were determined to be 0.523 and 1.585 µg/mL, respectively. The solubility of catechin hydrate in the solvent system was 114.631 µg/mL, as tested. Environmentally, the overall sustainability of this method, as measured by the Analytical Greenness (AGREE) tool, scored 0.84, and it was highly aligned with the principles of green analytical chemistry. In general, the method proposed is suitable for routine pharmaceutical and nutraceutical quality control analysis.

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