ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF REMOGLIFLOZIN ETABONATE BY RP-HPLC TECHNIQUE

Abstract

A simple, precise, accurate, and reproducible RP-HPLC method was developed and validated for the
estimation of Remogliflozin Etabonate in bulk drug and pharmaceutical dosage forms. Chromatographic
separation was achieved using a Thermo C18 column (250 mm × 4.6 mm, 5 μm) with a mobile phase
consisting of Methanol: Acetonitrile (50:50 v/v) at a flow rate of 1.0 mL/min. Detection was carried out at
238 nm using methanol as diluent. The retention time of Remogliflozin Etabonate was found to be 5.558 ±
0.03 min. The method exhibited good linearity in the concentration range of 1–5 μg/mL with a correlation
coefficient (R²) of 0.9999. The developed method was validated according to ICH guidelines for parameters
including accuracy, precision, linearity, robustness, limit of detection (LOD), and limit of quantification
(LOQ). The percentage recovery values were found within acceptable limits, indicating good accuracy of the
method. Precision studies showed low %RSD values, confirming reproducibility and reliability. The LOD
and LOQ values were found to be 0.15 μg/mL and 0.45 μg/mL respectively, demonstrating adequate
sensitivity of the method. The developed RP-HPLC method was found to be suitable for routine quantitative
analysis of Remogliflozin Etabonate in pharmaceutical formulations.