Sridevi Ranjitha Karanam
Nammi Poojitha
Dadi Vasudha
Yarraguntla Srinivasa Rao
Kollabathula Vara Prasada Rao
Разработаны методы измерения концентрации перорального противодиабетического препарата сотаглифлозина в форме таблеток, в том числе УФ-спектрофотометрические методы нулевого порядка, производных первого и второго порядков и высокоэффективной жидкостной хроматографии (ВЭЖХ). Метод A — УФ-спектрофотометрический метод нулевого порядка для определения сотаглифлозина в метаноле с максимумом поглощения при 254 нм. Метод B — спектрофотометрический метод производной первого порядка, метод C — производной второго порядка, измеряющие амплитуды при 264 и 234 нм. Метод D основан на ВЭЖХ, которая проводилась с использованием подвижной фазы колонки C18, состоящей из ацетонитрила: 0.1% ортофосфорной кислоты (40:60 об./об./об.) со скоростью потока 1 мл/мин и детектированием при 249 нм, что обеспечило острый пик с коротким временем удерживания 3.748 мин. Разработанные аналитические методы проверены статистически. Проведенный анализ показал, что оба подхода надежные и точные, RSD ˂ 1%. Значения извлечения (98–100%) находятся в пределах типичного диапазона. Проведено статистическое сравнение четырех аналитических методов, существенных различий не обнаружено.
Sotagliflozin is an oral antidiabetic medication that targets SGLT1 and SGLT2. This medication was not included in any pharmacopeia. The aim of this study was to develop, validate, and compare different methods for measuring the concentration of sotagliflozin in tablet form. These methods include spectrophotometric techniques such as zero-order UV spectrophotometry, first-order derivative spectroscopy, second-order derivative UV spectrophotometry, and high-performance liquid chromatography (HPLC). Method A was a simple zero-order UV spectrophotometric method established for the determination of sotagliflozin in methanol at 254 nm. Method B is a first-order derivative spectrophotometric method, and method C is a second-order derivative spectrophotometric method involving the measurement of amplitudes at 264 and 234 nm, respectively. Method D was performed using HPLC, which was carried out using a C18 column mobile phase consisting of acetonitrile:0.1% orthophosphoric acid (40:60 v/v/v) with a flow rate of 1 mL/min and detection at 249 nm, which provided a sharp peak with a short retention time of 3.748 min. The developed analytical methods were validated statistically. The analysis conducted using liquid chromatography and spectrophotometric methods revealed that both approaches were robust, precise, and accurate, with an RSD of less than 1%. The recovery values were (98–100%) within the typical range. The four analytical techniques were compared statistically, and no significant differences were found. For the quantitative analysis of sotagliflozin, it was discovered that these established procedures are reliable, quick, accurate, and easy to use, and they may also be applied for quality control testing.
The authors declare that there are no conflicts of interest present.