zhpsЖурнал прикладной спектроскопииZhurnal Prikladnoii Spektroskopii0514-7506B. I. Stepanov Institute of Physics of the National Academy of Scienceszhps-1937Research ArticleАННОТАЦИИ АНГЛОЯЗЫЧНЫХ СТАТЕЙABSTRACTS ENGLISH-LANGUAGE ARTICLESРазработка и валидация аналитического метода для определения метформина с использованием имитированной слюнной жидкости: предварительная формулировкаInnovative Analytical Method Development and Validation for Metformin Using Simulated Salivary Fluid: a Preformulation ApproachKuttyS. V.KuttyS. V.

Медицинский университет Кералы, фармацевтический колледж Грейс.

Палаккад, Керала

Sheeja Velayudhan Kutty - Grace College of Pharmacy, Department of Pharmaceutical Analysis.

Palakkad, Kerala

sheejasureshsree@yahoo.comShahlaT. S.ShahlaT. S.

Медицинский университет Кералы, фармацевтический колледж Грейс.

Палаккад, Керала

Grace College of Pharmacy, Department of Pharmaceutical Analysis.

Palakkad, Kerala

ShahshadP. P.ShahshadP. P.

Медицинский университет Кералы, фармацевтический колледж Грейс.

Палаккад, Керала

Grace College of Pharmacy, Department of Pharmaceutical Analysis.

Palakkad, Kerala

ShifaV. S.ShifaV. S.

Медицинский университет Кералы, фармацевтический колледж Грейс.

Палаккад, Керала

Grace College of Pharmacy, Department of Pharmaceutical Analysis.

Palakkad, Kerala

Медицинский университет КералыKerala University of Health Sciences202507092025924559559Copyright © Kutty S.V., Shahla T.S., Shahshad P.P., Shifa V.S., 20252025Kutty S.V., Shahla T.S., Shahshad P.P., Shifa V.S.Kutty S.V., Shahla T.S., Shahshad P.P., Shifa V.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/1937

Разработан УФ-спектрофотометрический метод для определения метформина гидрохлорида, используемого для лечения диабета 2-го типа. Метод протестирован в соответствии с рекомендациями ICH. Спектроскопические исследования проводились с использованием фосфатной слюнной жидкости в качестве растворителя, которая имитирует физиологическую жидкость в полости рта человека. Проведена оценка препарата по его органолептическим качествам, растворимости, pH, ИК-Фурье-спектроскопии, коэффициенту распределения, температуре плавления, содержанию влаги и свойствам текучести. Максимум поглощения для метформина в имитированной слюнной жидкости с pH 6.8 составил 233 нм, калибровочная кривая линейна в диапазоне концентраций 1–9 мкг/мл (r2 = 0.998). Исследования восстановления проводились при трех уровнях концентрации, результаты оказались в диапазоне 97–98.8%. Разработанный метод соответствует критериям специфичности, линейности и точности в предопределенных приемлемых пределах.

The current study aims to evaluate and assess the physiochemical characteristics of metformin hydrochloride, which is commonly used to treat type-Ⅱ diabetes. This study also focuses on the method development and validation of metformin hydrochloride by the UV-spectrophotometric method. The validation procedure adhered to the protocols specified by the ICH guidelines. The spectroscopic studies were done using simulated phosphate salivary fluid as a solvent, which mimics the physiological fluid in the human oral cavity. The drug was evaluated for its organoleptic assessment, solubility, pH, FTIR spectroscopy, partition coefficient, melting point, moisture content, and flow properties. The preformulation characteristics were thoroughly assessed and evaluated with the ranges specified in the monograph, and it was found to be within the limits. The absorption maxima for the drug using a simulated salivary fluid of pH 6.8 were found to be 233 nm, and the calibration curve for the metformin exhibited a linearity range of 1–9 µg/mL (r2 = 0.998). The recovery studies were done at three different concentration levels and were found to be in the range of 97–98.8%. This study evaluates how the developed method meets its criteria for specificity, linearity, and accuracy, within the predefined acceptance limits. Thus, a simple, accurate, and economical method is developed and validated along with the preformulation characteristics, which expands its utility in the formulation of the drug.

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