zhpsЖурнал прикладной спектроскопииZhurnal Prikladnoii Spektroskopii0514-7506B. I. Stepanov Institute of Physics of the National Academy of Scienceszhps-2099Research ArticleАННОТАЦИИ АНГЛОЯЗЫЧНЫХ СТАТЕЙABSTRACTS ENGLISH-LANGUAGE ARTICLESМетод производной второго порядка спектрофотометрии в УФ-видимой области для определения стабильности флунаризина дигидрохлоридаStability Indicating UV-Visible Spectrophotometric Method for the Estimation of Flunarizine Dihydrochloride Through Second-Order Derivative SpectroscopyRatreH.RatreHemant

Райпур, Чхаттисгарх

Department of Pharmaceutical Analysis & Quality Assurance

Raipur, Chhattisgarh

PandeyS.PandeySwati

Институт исследований и технологий фармацевтики имени Сагара

Бхопал, Мадхья-Прадеш

Department of Pharmaceutical Chemistry, Sage Institute of Research & Technology-Pharmacy

Bhopal, Madhya Pradesh

 

dubeyswati326@gmail.comPandeyR. K.PandeyRavindra Kumar

Кафедра фармакогнозии 

Райпур, Чхаттисгарх

Department of Pharmacognosy

Raipur, Chhattisgarh

ShuklaS. S.ShuklaShiv Shankar

Райпур, Чхаттисгарх

Department of Pharmaceutical Analysis & Quality Assurance

Raipur, Chhattisgarh

Колумбийский фармацевтический институтColumbia Institute of PharmacyУниверситет S.A.G.E.S.A.G.E. University202622012026931146146Copyright © Ratre H., Pandey S., Pandey R.K., Shukla S.S., 20262026Ratre H., Pandey S., Pandey R.K., Shukla S.S.Ratre H., Pandey S., Pandey R.K., Shukla S.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/2099

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Предложен УФ-спектроскопический метод производной второго порядка для определения флунаризина дигидрохлорида в активных фармацевтических ингредиентах (API) с использованием принудительной кислотной, основной, термической, фотолитической и окислительной деградации. Метод проверен в соответствии с руководящими принципами Международного совета по гармонизации (ICH). Обнаружен линейный отклик в диапазоне концентраций 10–60 мкг/мл при 253 нм. Относительное стандартное отклонение при исследовании межсуточной и внутрисуточной прецизионности составило <1.29% и <1.17%. В исследованиях ускоренной деградации флунаризина дигидрохлорида с использованием кислоты, щелочи, света и тепла отмечено снижение поглощения препарата на »10% как в лекарственной форме, так и в стандартном растворе. Разработанный аналитический метод валидации флунаризина дигидрохлорида с использованием спектроскопии производной второго порядка может быть использован для рутинного анализа.

The presented study is a simple, precise and accurate stability-indicating second-order UV derivative spectroscopic method that is being studied under the different stated International Council for Harmonization (ICH) Guidelines because of its forced-degradation properties, and to establish a validating method for Flunarizine dihydrochloride in active pharmaceutical ingredients (API). Adhering to ICH guidelines, the analytical parameters, viz. linearity, range, precision, and accuracy, were validated. The method was based on thorough stress testing utilizing acid, base, thermal, photolytic and oxidative degradations, and it was found that a linear response is present in the concentration range of 10–60 μg/mL at 253 nm. The % relative standard deviation (RSD) for precision studies of interday and intraday were <1.29 and <1.17%, respectively. The developed analytical method for validating flunarizine dihydrochloride using second-order derivative spectroscopy is found to be simple and precise, and the percentage recovery was found to be within acceptable limits. It can be conveniently used for routine analysis. In the forced degradation studies of flunarizine dihydrochloride utilizing various parameters, such as acid, alkali, light and heat, the absorbance of the drug was noted to have decreased approximately 10% in both the formulation and the standard. Based on the results obtained, it was found that the proposed method is accurate, precise, and reproducible, and can be employed for quality control analysis.

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