Development and Validation of HPLC, HPTLC and UV method for the Quantitative Analysis of Remogliflozin Etabonate

Abstract

Remogliflozin Etabonate (RE), a sodium-glucose co-transporter-2 (SGLT2) inhibitor, is widely used in the treatment of type 2 diabetes mellitus. The present study aimed to develop and validate simple, rapid, accurate, and economical RP-HPLC, RP-HPTLC, and UV-AUC spectroscopic methods for the quantitative estimation of RE in bulk drug and tablet dosage forms. RP-HPLC analysis was performed on a Qualisil BDS-C18 column (250 × 4.6 mm, 5 µm) using methanol: water (95:05, v/v) as the mobile phase at a flow rate of 1.0 mL/min, with detection at 227 nm. The RP-HPTLC method employed TLC Silica Gel 60 RP-18 F254S plates and a mobile phase comprising chloroform: ethyl acetate: ammonia (2.5:2:0.5, v/v/v), with densitometric scanning at 227 nm. The UV-AUC method utilized methanol as the solvent, and quantification was carried out over the wavelength range of 227–229 nm. The developed methods were validated in accordance with ICH Q2(R1) guidelines for linearity, accuracy, precision, sensitivity, robustness, and specificity. The RP-HPLC, RP-HPTLC, and UV-AUC methods exhibited excellent linearity over concentration ranges of 2–10 µg/mL, 200–1200 ng/band, and 5–30 µg/mL, respectively, with correlation coefficients greater than 0.997. Recovery studies demonstrated satisfactory accuracy, while precision studies showed low %RSD values, confirming the reproducibility of the methods. The developed methods were successfully applied to the assay of marketed tablet formulations, producing results within acceptable limits. The proposed analytical methods are simple, reliable, precise, and cost-effective, making them suitable for routine quality control and quantitative analysis of Remogliflozin Etabonate in pharmaceutical dosage forms.