zhpsЖурнал прикладной спектроскопииZhurnal Prikladnoii Spektroskopii0514-7506B. I. Stepanov Institute of Physics of the National Academy of Scienceszhps-1366Research ArticleАННОТАЦИИ АНГЛОЯЗЫЧНЫХ СТАТЕЙABSTRACTS ENGLISH-LANGUAGE ARTICLESСпектрофлуориметрический метод определения иделалисиба в нерасфасованном виде и фармацевтических составахValidated Spectrofluorimetric Method for Estimation of Idelalisib in Bulk and in FormulationMaheshM.MaheshM.

Чандигарх

Chandigarh

BaliA.BaliA.

Чандигарх

Chandigarh

alka.bali@rediffmail.comGuptaT.GuptaT.

Чандигарх

Chandigarh

Центр перспективных исследований UGC Пенджабского университетаUniversity Institute of Pharmaceutical Sciences, UGC Center of Advanced Study at Panjab University202325082023904655655Copyright © Mahesh M., Bali A., Gupta T., 20232023Mahesh M., Bali A., Gupta T.Mahesh M., Bali A., Gupta T.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/1366

Иделалисиб представляет собой дельта-ингибитор фосфатидилинозитол-3-киназы, одобренный USFDA и EMA для лечения лимфолитической лимфомы, В-клеточной неходжкинской лимфомы и лимфоцитарной лимфомы. Описаны простые, чувствительные и экономичные спектрофлуориметрические методы, основанные на нативной флуоресценции лекарственного средства в кислой среде. Обнаружено, что характеристики флуоресценции препарата значительно различаются в абсолютном этаноле (λex = 330 и λem = 595 нм) и HCl (λex = 270 и λem = 350 нм). Методы валидированы в соответствии с рекомендациями ICH, демонстрируют превосходную линейность в диапазонах концентраций 0.1–2.0 мкг/мл (абсолютный этанол) и 0.1–20 мкг/мл (HCl), LOD и LOQ составляют 0.015 и 0.045 мкг/мл (этанол) и 0.1615 и 0.4894 мкг/мл (HCl). Предложенные методы использованы для количественного определения лекарственного средства в таблетированной форме с хорошим выходом, что позволяет предположить их применимость для рутинного анализа лекарственного средства в нерасфасованном виде. 

Idelalisib is a phosphatidylinositol 3-kinase delta inhibitor approved by the USFDA and EMA for the treatment of lympholytic lymphoma, B-cell non-Hodgkin lymphoma and lymphocytic lymphoma. The present report describes the validation of simple, rapid, sensitive, and cost-effective spectrofluorimetric methods based on the native fluorescence of the drug in an acidic medium. Fluorescence characteristics of the drug were found to significantly differ in absolute ethanol (λex = 330 and λem = 595 nm) and HCl (λex = 270 and λem = 350 nm) and both methods were validated as per ICH guidelines. The two methods were extremely sensitive, precise and accurate demonstrating excellent linearity in concentration ranges from 0.1–2.0 μg/mL (absolute ethanol) and 0.1–20 μg/mL (HCl). The LOD and LOQ values were found to be 0.015 and 0.045 µg/mL (ethanol) and 0.1615 and 0.4894 µg/mL (HCl). The proposed methods were used to quantify the drug in its marketed tablet formulation with good recoveries, suggesting their applicability to routine analysis of the drug in bulk as well as in formulation.

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