zhpsЖурнал прикладной спектроскопииZhurnal Prikladnoii Spektroskopii0514-7506B. I. Stepanov Institute of Physics of the National Academy of Scienceszhps-1370Research ArticleАННОТАЦИИ АНГЛОЯЗЫЧНЫХ СТАТЕЙABSTRACTS ENGLISH-LANGUAGE ARTICLESСпектрофотометрические методы количественного определения противосудорожного препарата зонисамида в присутствии продукта его окислительной деградацииValidated Stability Indicating Spectrophotometric Methods for Quantitative Determination of Anticonvulsant Drug Zonisamide in the Presence of Its Oxidative Degradation ProductElsheikhS. G.ElsheikhS. G.

Гиза

Giza

HassanA.M.E.HassanA.M.E.

Гиза

Giza

FayezY. M.FayezY. M.

Каср-эль-Айни, Каир

Analytical Chemistry Department, Faculty of Pharmacy, 

Kasr El Aini, Cairo

El-MosallamyS. S.El-MosallamyS. S.

Каср-эль-Айни, Каир

Analytical Chemistry Department, Faculty of Pharmacy, 

Kasr El Aini, Cairo

sally.el-mosallamy@pharma.cu.edu.egУниверситет 6 ОктябряAnalytical Chemistry Department, Faculty of Pharmacy, October 6 UniversityКаирский университетCairo University202328082023904659659Copyright © Elsheikh S.G., Hassan A., Fayez Y.M., El-Mosallamy S.S., 20232023Elsheikh S.G., Hassan A., Fayez Y.M., El-Mosallamy S.S.Elsheikh S.G., Hassan A., Fayez Y.M., El-Mosallamy S.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/1370

Для оценки противосудорожного препарата зонисамида в присутствии продукта его окислительного разложения разработаны четыре простых и воспроизводимых спектрофотометрических метода. Проиллюстрирован путь деградации, структура продукта деградации установлена с помощью инфракрасной и масс-спектроскопии. Предложены прямой спектрофотометрический метод (D0), метод первой производной (D1), метод разности отношений (RD) и метод первой производной отношений спектров (1DD). Методы показали хорошую чувствительность и высокую воспроизводимость, диапазоны линейности 5–40 мкг/мл для первого метода и 2–40 мкг/мл для трех других методов, средние проценты восстановления: 100.12±0.590 для D0 , 99.97±0.606 для D1, 99.88±0.546 для RD и 99.94±0.619 для 1DD. Методы применены для анализа синтетических смесей с разным содержанием зонисамида и продукта его окислительного разложения. Предложенные методы проверены в соответствии с рекомендациями ICH. Статистический анализ не выявил существенных различий по сравнению с официальной методикой.

Four simple, reproducible and rapid stability-indicating spectrophotometric methods were developed and efficiently applied for the estimation of zonisamide (anticonvulsant drug) in the presence of its oxidative degradation product. The degradation pathway was clearly illustrated and the structure of the degradation product was elucidated by infrared and mass spectroscopy. The proposed methods were the direct spectrophotometric method (D0), the first derivative method (D1), the ratio difference method (RD) and, finally, the first derivative of the ratio spectra method 1DD. Good sensitivity and high reproducibility were obtained via the developed methods. Linearity ranges were 5–40 µg/mL for the first method and 2–40 µg/mL for the other three methods. Mean recovery percentages of the methods were 100.12±0.590 for D0, 99.97±0.606 for D1, 99.88±0.546 for RD, and 99.94±0.619 for 1DD. The specificity of the methods was investigated by analyzing synthetic mixtures of different percentages of zonisamide and its oxidative degradation product. The proposed methods were validated in accordance with ICH guidelines. Statistical analysis showed no significant differences in comparison with the official method.

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