zhpsЖурнал прикладной спектроскопииZhurnal Prikladnoii Spektroskopii0514-7506B. I. Stepanov Institute of Physics of the National Academy of Scienceszhps-2430Research ArticleАННОТАЦИИ АНГЛОЯЗЫЧНЫХ СТАТЕЙABSTRACTS ENGLISH-LANGUAGE ARTICLESОпределение содержания гидробромида галантамина в фармацевтических препаратах и образцах урины с использованием ИК- и УФ-спектроскопии для исследования его принудительной деградацииUse of Infrared and Ultraviolet Spectroscopy for Galantamine Hydrobromide Assay in Pharmaceuticals and Spiked Human Urine with an Emphasis on Forced Degradation StudyNehaK. M.NehaK. M.

Майсур, Карнатака

Mysuru, Karnataka

RajendraprasadN.RajendraprasadN.

Майсур, Карнатака

Mysuru, Karnataka

prasadtnpur@gmail.comКолледж искусств, коммерции и науки Университета МайсураИндияPG Department of Chemistry, JSS College of Arts, Commerce and Science (A Research Centre Recognised by the University of Mysore)India202628092026935733733Copyright © Neha K., Rajendraprasad N., 20262026Neha K., Rajendraprasad N.Neha K., Rajendraprasad N.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/2430

Разработаны и валидированы два УФ-спектрофотометрических метода для определения гидробромида галантамина (GHB) (препарата против болезни Альцгеймера и обратимого ингибитора ацетилхолинэстеразы) в фармацевтических препаратах и образцах урины человека с добавлением GHB.

 

 

** Full text is published in JAS V. 93, No. 5 (http://springer.com/journal/10812) and in electronic version of ZhPS V. 93, No. 5 (http://www.elibrary.ru/title_about.asp?id=7318; sales@elibrary.ru).

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В методе А измеряли поглощение раствора GHB в 0.1 М уксусной кислоте (HOAc) на длине волны 293 нм. Препарат демонстрировал тот же максимум поглощения в 0.1 М соляной кислоте (HCl), которая использована для метода B. Обеспечена хорошая линейность в диапазоне концентраций 0.8–80 мкг/мл GHB с коэффициентами корреляции 0.9807 и 0.9988 для методов A и B, пределы обнаружения 0.1477 и 0.3082 мкг/мл, пределы количественного определения 0.4476 и 0.9340 мкг/мл соответственно, что указывает на высокую чувствительность методов. Чувствительность по Санделлу 0.1208 и 0.1175 мкг/см² для методов А и B. Исследования точности и прецизионности показали низкую относительную погрешность RSD  2 %. Надежность подтверждена изменением аналитической длины волны на ±2 нм без существенных изменений поглощения. Исследования устойчивости продемонстрировали стабильные результаты у разных аналитиков и приборов. Анализ таблетированных составов с использованием метода стандартного добавления показал средние процентные показатели извлечения 98.45% и 100.31% для методов А и В, что свидетельствует о хорошей селективности. Методы использованы для анализа образцов урины человека с добавлением аналита. Исследования принудительной деградации установили стабильность методов, выявив значительную деградацию в кислых средах и хорошую стабильность при термическом воздействии, что дополнительно подтверждено результатами ИК-Фурье-спектроскопии. Разработанные методы пригодны для рутинного контроля качества и терапевтического мониторинга GHB.

Galantamine hydrobromide (GHB) is an anti-Alzheimer’s drug and a reversible acetylcholinesterase inhibitor. Two simple, sensitive and stability-indicating ultraviolet (UV) spectrophotometric methods were developed and validated for the determination of GHB in pharmaceuticals and a spiked human urine sample. In Method A, the absorbance of the GHB solution in 0.1 M acetic acid (HOAc) was measured at 293 nm. The drug exhibited the same absorbance maximum in 0.1 M hydrochloric acid (HCl), which served as the basis for Method B. Good linearity was ensured over the concentration range of 0.8–80 µg/mL GHB, with correlation coefficients of 0.9807 and 0.9988 for methods A and B, respectively, and the corresponding limits of detection were 0.1477 and 0.3082 µg/mL, while the limits of quantification were 0.4476 and 0.9340 µg/mL, indicating high sensitivity. The Sandell sensitivity values were calculated to be 0.1208 µg/cm² for method A and 0.1175 µg/cm² for method B. Accuracy and precision studies showed low relative error, and %RSD values were below 2%. Robustness was confirmed by deliberate variation of the analytical wavelength by ±2 nm without significant changes in absorbance, while ruggedness studies demonstrated consistent results across different analysts and instruments. Assay of tablet formulations using the standard-addition method yielded the mean percentage recoveries of 98.45 and 100.31% in methods A and B, indicating excellent selectivity. The successful application of the proposed methods to a spiked human urine sample confirmed their biological applicability. Forced degradation studies established the stability-indicating nature of the methods, revealing significant degradation under acidic conditions and good stability under thermal stress, which was further supported by observations in FTIR spectral analysis. The developed methods are rapid, cost-effective and reliable, making them suitable for routine quality control and therapeutic monitoring of GHB.

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