zhpsЖурнал прикладной спектроскопииZhurnal Prikladnoii Spektroskopii0514-7506B. I. Stepanov Institute of Physics of the National Academy of Scienceszhps-1678Research ArticleАННОТАЦИИ АНГЛОЯЗЫЧНЫХ СТАТЕЙABSTRACTS ENGLISH-LANGUAGE ARTICLESМетоды производных УФ-спектрофотометрии для определения ивакафтораDerivative UV-Spectrophotometric Assay Methods for Determination of IvacaftorBishnoiA.BishnoiA.

Aastha Bishnoi

Институт фармацевтических наук; Центр перспективных исследований UGC

Чандигарх

Aastha Bishnoi

University Institute of Pharmaceutical Sciences; UGC Center of Advanced Study

Chandigarh

ake@neicon.ruBaliA.BaliA.

Alka Bali

Институт фармацевтических наук; Центр перспективных исследований UGC

Чандигарх

Alka Bali

University Institute of Pharmaceutical Sciences; UGC Center of Advanced Study

Chandigarh

alka.bali@rediffmail.comfKumarA.KumarA.

Akshay Kumar

Институт фармацевтических наук; Центр перспективных исследований UGC

Чандигарх

Akshay Kumar

University Institute of Pharmaceutical Sciences; UGC Center of Advanced Study

Chandigarh

Пенджабский университетPanjab University202424102024915760760Copyright © Bishnoi A., Bali A., Kumar A., 20242024Bishnoi A., Bali A., Kumar A.Bishnoi A., Bali A., Kumar A.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/1678

   Ивакафтор — селективный низкомолекулярный белок-регулятор трансмембранной проводимости, используемый для лечения муковисцидоза. Описаны простые, чувствительные и экономически эффективные спектрофотометрические методы производных нулевого и первого порядка для оценки ивакафтора в нерасфасованном виде и в фармацевтическом составе. Предварительный спектрофотометрический анализ препарата проведен в метаноле и всего рассмотрен 21 параметрический вариант. Три выбранных варианта, использующие методы поглощения (нулевой порядок), пик-пик (первый порядок) и пик-ноль (второй порядок), оценены на предмет их стабильности, указывающей на потенциал в растворах лекарственного препарата, подвергшихся стрессовой деградации. Разработанный метод проверен на линейность, точность, прецизионность, надежность и стабильность решения. В диапазоне концентраций 5.0–30.0 мкг/мл наблюдается линейность с коэффициентом корреляции 0.99 и выше для выбранных вариантов метода. Пределы обнаружения 0.90–1.06 мкг/мл, пределы количественного определения 2.72–3.22 мкг/мл для предложенных вариантов метода. Методы использованы для количественного определения препарата в его таблетированной форме, получены хорошие показатели извлечения в диапазоне 95.98–98.81 %.

   Ivacaftor is a selective small molecule potentiator Transmembrane Conductance Regulator protein used for the treatment of cystic fibrosis. This report describes the validation of simple, rapid, sensitive and cost-effective zero-order and first-order derivative spectrophotometric methods for the estimation of ivacaftor in bulk and in its marketed formulation. Preliminary spectrophotometric analysis of the drug was carried out in methanol and a total of 21 parametric variations were considered. Three selected method variants employing absorbance (zero-order), peak-peak (first order) and peak-zero (second order) techniques were assessed for their stability indicating potential in stress degraded solutions of the drug. The developed method was validated with respect to parameters including linearity, accuracy, precision, robustness and solution stability. Excellent linearity was observed in the concentration range of 5.0–30.0 μg/mL with a correlation coefficient of 0.99 and above for the selected method variants. The limits of assay detection values ranged from 0.90–1.06 μg/mL, and quantitation limits ranged from 2.72–3.22 μg/mL for the proposed method variants. The proposed methods were used to quantify the drug in its marketed tablet formulation, and good recoveries ranging from 95.98 to 98.81 % were obtained.

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