zhpsЖурнал прикладной спектроскопииZhurnal Prikladnoii Spektroskopii0514-7506B. I. Stepanov Institute of Physics of the National Academy of Scienceszhps-1774Research ArticleАННОТАЦИИ АНГЛОЯЗЫЧНЫХ СТАТЕЙABSTRACTS ENGLISH-LANGUAGE ARTICLESСпектрофотометрический метод количественного анализа стабилизатора транстиретина — тафамидисаSPECTROPHOTOMETRIC APPROACH FOR QUANTITATIVE ANALYSIS OF A NEW TRANSTHYRETIN STABILIZER: TAFAMIDISAgarwalN.AgarwalN.

Вайл Парле Вест, Мумбаи, Махараштра

Vile Parle West, Mumbai, Maharashtra

rcpatil19092000@gmail.comPatilR.PatilR.

Вайл Парле Вест, Мумбаи, Махараштра

Vile Parle West, Mumbai, Maharashtra

SharmaS.SharmaS.

Вайл Парле Вест, Мумбаи, Махараштра

Vile Parle West, Mumbai, Maharashtra

Школа фармацевтики и управления технологиями имени Шобхабена Пратапбхаи Пателя, Национальный институт медицинских наук SVKMShobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM’s NMIMS Deemed to be University202507022025921135135Copyright © Agarwal N., Patil R., Sharma S., 20252025Agarwal N., Patil R., Sharma S.Agarwal N., Patil R., Sharma 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/1774

Разработан простой, экономически эффективный, точный УФ-спектрофотометрический метод анализа препарата тафамидиса. Специфичность, линейность, точность, прецизионность, предел обнаружения, предел количественного определения и надежность оценены в соответствии с руководящими принципами ICH Q2(R1). Препарат характеризуется максимумом поглощения λ = 310 нм и стабильностью раствора в течение 12 ч. Метод демонстрирует линейность отклика для концентраций тафамидиса 2–12 мкг/мл и описывается уравнением y = 0.1724x – 0.0443 с R2  = 0.9995, точность варьирует 100 до 103%, предел обнаружения 0.112 мкг/мл, предел количественного определения 0.34 мкг/мл. 

The development of simple to use, cost-effective, accurate, and precise UV spectrophotometry is the objective of this study. Validation characteristics such as specificity, linearity, accuracy, precision, limit of detection, limit of quantification, and robustness were evaluated in accordance with ICH Q2(R1) guidelines. The drug was measured to have the maximum absorbance at a wavelength of 310 nm. The solution remains stable for up to 12 h. The equation y = 0.1724x – 0.0443, with an R2  of 0.9995, was used to demonstrate the linear response for tafamidis concentration ranges of 2–12 μg/mL. It was found that the accuracy ranged from 100–103%. The intraday and interday precision for repeatability fell within the acceptable parameters (<2%). The technique’s limit of detection was 0.112 μg/mL and the limit of quantification was 0.34 μg/mL. The proposed validated method can be applied to standard quality control purposes as well as tafamidis analysis in pharmaceutical doses form. 

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