Development and Validation of a Robust RP-HPLC Method for the Estimation of Remogliflozin Etabonate in Bulk and Tablet Dosage Forms

ABSTRACT: Remogliflozin etabonate, a selective inhibitor of SGLT2, is prescribed for managing type 2 diabetes mellitus. To support quality control and routine testing, a dependable and efficient analytical technique is essential. The present study consists of a rapid, precise, and straightforward Reverse-Phase High-Performance Liquid Chromatography (RP-HPLC) method development for quantifying remogliflozin etabonate. An Inertsil ODS-3V column (150*4.6 mm, 5 µm) was used for separation. Optimization of the mobile phase was done from methanol: water (70:30, v/v) to acetonitrile: water (75:25, v/v), flow rate of 1.0 mL/min, and samples were analysed at 230 nm using a UV detector. ICH Q2(R1) was followed for validation of the method to assess various parameters like linearity, accuracy, precision, robustness, LOD, and LOQ. The assay demonstrated excellent linearity over 10–50 µg/mL (R² = 0.999), with a retention time of 2.55 min. Precision results showed %RSD values below 2%, while recovery studies confirmed accuracy within 98–102%. The calculated LOD and LOQ were 0.22 µg/mL and 0.68 µg/mL, respectively. The validated technique proved to be simple and robust, with adequate specificity, and can be effectively applied for routine analysis of remogliflozin etabonate in bulk as well as pharmaceuticals.