zhpsЖурнал прикладной спектроскопииZhurnal Prikladnoii Spektroskopii0514-7506B. I. Stepanov Institute of Physics of the National Academy of Scienceszhps-1054Research ArticleСтатьиРазработка и валидация УФ-спектрофотометрического метода определения гидрохлорида эрлотинибаDevelopment and Validation of the Ultraviolet Spectrophotometric Method for Determination of Erlotinib HydrochlorideJadavR. A.JadavR. A.

Хадия, Гуджарат

Khadia, State-Gujarat

jadavrajesh055@gmail.comAmbasanaM. A.AmbasanaM. A.

Хадия, Гуджарат

Khadia, State-Gujarat

BapodraA. H.BapodraA. H.

Хадия, Гуджарат

Khadia, State-Gujarat

Университет Бхакта Кави Нарсин Мехта, Государственный политехнический кампусDepartment of Chemistry and Forensic Science, Bhakta Kavi Narsinh Mehta University, Government Polytechnic Campus202225052022893369373Copyright © Jadav R.A., Ambasana M.A., Bapodra A.H., 20222022Jadav R.A., Ambasana M.A., Bapodra A.H.Jadav R.A., Ambasana M.A., Bapodra A.H.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/1054

Разработан простой, точный и безопасный метод определения содержания эрлотиниба гидрохлорида в лекарственной форме в виде таблеток с использованием смеси метанола и ацетонитрила (50:50 об.%). Максимальное и дополнительное пиковое поглощение эрлотиниба гидрохлорида отмечено на длинах волн 247 и 333 нм, что подчиняется закону Бера в диапазоне концентраций 5–30 мкг/мл (r2 = 0.9992). В предлагаемом методе для оценки концентрации эрлотиниба гидрохлорида в таблетках использована длина волны дополнительного пикового поглощения 333 нм. Уравнение линейной регрессии y = 0.0461x + 0.0164. Разработанный метод проверен в соответствии с рекомендациями Международной конференции по гармонизации (ICH). Показатели точности и другие статистические переменные соответствуют заданным значениям.

A simple, accurate, novel, safe, and precise method was developed for the estimation of erlotinib hydrochloride in tablet dosage form using a mixture of methanol and acetonitrile (50:50% V/V). The maximum and subsidiary peak absorption of erlotinib hydrochloride were noted at 247 and 333 nm, respectively. Erlotinib hydrochloride follows Beer’s law in the concentration range of 5–30 μg/mL (r2 = 0.9992). In the proposed method, the subsidiary peak absorption wavelength of 333 nm was used to estimate the concentration of erlotinib hydrochloride in tablets. The linear regression equation was found to be y = 0.0461x + 0.0164. The developed method was validated according to the International Conference on Harmonization (ICH) guidelines, and the values of accuracy, precision, and other statistical variables were found to be in accordance with the prescribed values.

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