A validated RP-HPLC bioanalytical method for the quantification of remogliflozin etabonate in spiked human plasma

Remogliflozin etabonate, a selective sodium-dependent glucose transporter 2 antagonist, reduces glucose levels in type 2 diabetes by inhibiting renal glucose reabsorption. This study developed a bioanalytical reverse-phase high-performance liquid chromatography method for quantifying remogliflozin etabonate in human plasma. The method utilized a Kromasil C18 column (250 mm × 4.6 mm; 5 μm), with detection at 228 nm and selexipag as the internal standard. The mobile phase comprised acetonitrile and 0.1% orthophosphoric acid in water (70:30, v/v), and separation was performed in an isocratic mode with a flow rate of 1.0 mL/min. The analyte was isolated from the spiked plasma matrix using the protein precipitation technique. Remogliflozin etabonate and selexipag eluted at 4.08 and 9.06 min, respectively. The method demonstrated satisfactory linearity (1.50–60 µg/mL, r² = 0.9998) and high extraction recovery (97.46%–99.21%). Stability studies confirmed accuracy within ± 15%, %CV < 6%, and no significant degradation of remogliflozin etabonate. The developed method can be applied for routine analysis of remogliflozin etabonate in spiked human plasma samples.