zhpsЖурнал прикладной спектроскопииZhurnal Prikladnoii Spektroskopii0514-7506B. I. Stepanov Institute of Physics of the National Academy of Scienceszhps-1240Research ArticleАННОТАЦИИ АНГЛОЯЗЫЧНЫХ СТАТЕЙABSTRACTS ENGLISH-LANGUAGE ARTICLESЭкологически безопасные и стабильные спектроскопические методы обнаружения гидрохлорида цинакальцетаEco-Friendly and Stability Indicating Spectroscopic Methods for Cinacalcet Hydrochloride: Method Development, Validation, and Application in Its Pharmaceutical FormulationsAcharjyaS. K.AcharjyaS. K.

Одиша

sasmita_acharjya@yahoo.com

Odisha

acharjya2009@gmail.comKumarN. K.KumarN. K.

Одиша

Odisha

DashS. K.DashS. K.

Одиша

Odisha

ChakrabortyA.ChakrabortyA.

Одиша

Odisha

PatraC. N.PatraC. N.

Одиша

Odisha

Институт фармацевтических наук РоландаRoland Institute of Pharmaceutical Sciences, Dept. of Pharmaceutical Analysis and Quality Assurance202304022023901126126Copyright © Acharjya S.K., Kumar N.K., Dash S.K., Chakraborty A., Patra C.N., 20232023Acharjya S.K., Kumar N.K., Dash S.K., Chakraborty A., Patra C.N.Acharjya S.K., Kumar N.K., Dash S.K., Chakraborty A., Patra C.N.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/1240

Разработаны и проверены четыре экологически чистых и стабильных спектроскопических метода оценки кальциймиметического лекарственного средства цинакальцета гидрохлорида (CIN) в различных фармацевтических составах. Реакция стандартного раствора измерена в 0.1N HCl в качестве разбавителя (безопасного) при 279, 294 и 299 нм для УФ-спектрофотометрии и ее первой и второй производных соответственно. Спектрофотометрический метод AUC заключается в расчете площади под кривой (AUC) в диапазоне длин волн 266—286 нм. Графики линейности методов построены по значениям [абсорбция, (dA/dλ), (d2A/dλ2) или AUC] в зависимости от концентрации и показывают выполнение закона Бера в диапазоне концентраций 2.5—200 мкг/мл для всех методов. В ходе исследования препарат был подвергнут различным стрессовым воздействиям в соответствии с рекомендациями Международной конференции по гармонизации Q1A-Q1E. Проверочные параметры методов находятся в допустимых пределах согласно рекомендациям Международной конференции по гармонизации ICH Q2R(1). Экологичность разработанных УФ-спектроскопических инструментов оценена с использованием Национального индекса экологических методов, аналитической экологической шкалы и метрического подхода AGREE. Все методы доказали свою экологичность в отношении растворителей, химикатов, потребляемой энергии и образующихся отходов. Экологически безопасные спектроскопические методы позволяют определять количество CIN в различных лекарственных формах, не оказывая влияния на окружающую среду. 

The present paper explains the development and validation of four new eco-friendly and stabilityindicating spectroscopic methods of estimating a calcimimetic drug, i.e., cinacalcet hydrochloride (CIN), in its different pharmaceutical formulations. In these methods, the response of the standard solution is measured in 0.1N HCl as a diluent (nonhazardous) at 279, 294, and 299 nm for UV, first-, and second-order derivative spectrophotometric tools, respectively. The AUC-spectrophotometric technique is carried out by calculating the area under the curve (AUC) between the wavelength regions ranging from 266 to 286 nm. The linearity graph of the methods is plotted by taking response [Absorbance/(dA/dλ)/(d2A/dλ2) or AUC] values against the concentration and shows that the drug obeys Beer’s law within the concentration range 2.5 to 200 μg/mL for all the methods. The drug is exposed to various stress conditions as recommended by the ICH Q1A-Q1E guideline. The different method validation parameters are within the acceptable limit as per the ICH Q2R(1) guideline. The greenness profile of the developed UV spectroscopic tools is evaluated using the National Environmental Methods Index, the Analytical Eco-Scale, and the Analytical GREEnness (AGREE) metric approach. All approaches prove the greenness of the methods concerning solvent, chemicals, energy consumed, and waste produced. Eco-friendly spectroscopic methods can determine the quantity of CIN in various pharmaceutical dosage forms without influencing the environment and analysts. 

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