Estimation of Sotagliflozin in Tablet Dosage Form Using UV-Spectrophotometric and RP-HPLC Techniques: a Comparative Study

Abstract

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.