zhpsЖурнал прикладной спектроскопииZhurnal Prikladnoii Spektroskopii0514-7506B. I. Stepanov Institute of Physics of the National Academy of Scienceszhps-1581Research ArticleАННОТАЦИИ АНГЛОЯЗЫЧНЫХ СТАТЕЙABSTRACTS ENGLISH-LANGUAGE ARTICLESСпектрофлуориметрические методы определения валбеназина тозилата в нерасфасованном виде и капсулахSpectrofluorimetric Methods for Estimation of Valbenazine Tosylate in Bulk and in Capsule FormulationGuptaT.GuptaT.

Пенджабский университет, Чандигарх

University Institute of Pharmaceutical Sciences, 

Panjab University, Chandigarh

BaliA.BaliA.

Пенджабский университет, Чандигарх

University Institute of Pharmaceutical Sciences, 

Panjab University, Chandigarh

alka.bali@rediffmail.comMaheshM.MaheshM.

Пенджабский университет, Чандигарх

University Institute of Pharmaceutical Sciences, 

Panjab University, Chandigarh

ShekharS.ShekharS.

Пенджабский университет, Чандигарх

University Institute of Pharmaceutical Sciences, 

Panjab University, Chandigarh

Институт фармацевтических наук Центра перспективных исследований UGCUGC Center of Advanced Study202431052024913467467Copyright © Gupta T., Bali A., Mahesh M., Shekhar S., 20242024Gupta T., Bali A., Mahesh M., Shekhar S.Gupta T., Bali A., Mahesh M., Shekhar 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/1581

Для определения валбеназина тозилата разработаны спектрофлуориметрические методы, основанные на нативной флуоресценции лекарственного средства в кислой, основной и нейтральной средах. Стабильность методов оценена путем исследования восстановления в растворах принудительно разложившегося препарата. Методы охарактеризованы в соответствии с принципами Международного совета по гармонизации по линейности, точности, прецизионности, пределу обнаружения, пределу количественного определения и устойчивости. Отличная линейность отмечена в диапазоне концентраций 2.0–30.0 мкг/мл (0.1 н. соляная кислота), 0.5–15.0 мкг/мл (0.1 н. гидроксид натрия), 0.1–20.0 мкг/мл (вода) с коэффициентами корреляции 0.9963, 0.9989 и 0.9998. Пределы обнаружения и количественного определения для предложенных методов находятся в диапазонах 0.025—0.044 и 0.077—0.1357 мкг/мл. Методы использованы для количественного определения препарата в форме капсул с хорошими показателями извлечения, что позволяет предположить их применимость для рутинного анализа как в нерасфасованном виде, так и в рецептурных препаратах.

Valbenazine tosylate, a benzoquinolizidine derivative, is a highly selective vesicular monoamine transporter 2 inhibitor. The drug has been approved by the FDA as the first and only approved treatment for tardive dyskinesia. To our knowledge, this is the first report on the development and validation of simple, rapid, sensitive, and cost-effective spectrofluorimetric methods based on the native fluorescence of the drug in acidic, basic and neutral medium. The stability-indicating potential of the method was assessed by recovery studies in the forced degraded solutions of the drug. The method was validated in accordance with the International Council for Harmonisation guidelines with respect to linearity, accuracy, precision, limit of detection, limit of quantification, and robustness. Excellent linearity was noted within the concentration range 2.0–30.0 µg/mL (0.1 N hydrochloric acid), 0.5–15.0 µg/mL (0.1 N sodium hydroxide), 0.1–20.0 µg/mL (water) with corresponding correlation coefficients of 0.9963, 0.9989, and 0.9998. Limits of detection and quantitation for the proposed methods were found to range from 0.025 to 0.044 and from 0.077 to 0.1357 µg/mL, respectively, for the three methods. The proposed methods were used to quantify the drug in its marketed capsule 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.