Asian Journal of Pharmaceutical Analysis
  • Year: 2024
  • Volume: 14
  • Issue: 4

Development and Validation of RP-HPLC Method for Simultaneous Quantification of Remogliflozin and Metformin in Marketed Dosage forms

Department of Pharmaceutical Analysis, GITAM School of Pharmacy, GITAM (Deemed to be University), Rushikonda, Visakhapatnam, Andhra Pradesh, India, Pin-530045

*Corresponding Author E-mail: duttaarijit2307@gmail.com

Online published on 15 April, 2025.

Abstract

A simple, rapid, affordable, precise, and accurate RP-HPLC technique for simultaneous quantification of Remogliflozin Etabonate and Metformin HCL in their synthetic mixture and tablet dosage form has been devised. A reverse-phase high-performance liquid chromatographic method has been devised to simultaneously quantify Remogliflozin Etabonate and Metformin HCL in their Synthetic Mixture. Chromatographic separation was obtained using a Phenomenex Luna (250mm × 4.6mm, 5μm) C8 column with a mobile phase consisting of 0.1% v/v orthophosphoric acid and acetonitrile in the ratio of 30:70 % v/v, at a 0.9mL/min. Detection was carried out at 230nm. The retention time of Remogliflozin Etabonate and Metformin HCL was 4.63min and 2.09 min, respectively. Linearity was observed for Remogliflozin Etabonate 0.1-20μg/mL and for Metformin HCL 0.5-100μg/mL. The method devised for quickly, precisely, and accurately quantifying Metformin HCl and Remogliflozin Etabonate in their synthetic mixture was effective. Stress conditions that comprised hydrolysis, oxidation, thermal degradation and photolysis were applied. The suggested technique, which worked well for simultaneously quantifying both drugs in a commercial synthetic mixture.

Keywords

Remogliflozin Etabonate, Metformin HCl, RP-HPLC, Validation, Simultaneous Quantification