Abstract

STABILTY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF REMOGLIFLOZIN ETABONATE AND METFORMIN HCL IN SYNTHETIC MIXTURE AND TABLET DOSAGE FORM

Shivani V. Trivedi*

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Abstract

A simple, rapid, economical, precise and accurate Stability indicating RP- HPLC method for simultaneous estimation of Remogliflozin Etabonate and Metformin Hcl in their Synthetic Mixture and tablet dosage form has been developed. A reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of remogliflozin etabonate and metformin hcl in their Synthetic Mixture has been developed. The separation was achievedby Cosmosil C18 (250mm x 4.6mm, 5μm) column and Buffer (pH 4.0): methanol (60:40) as mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 241 nm. Retention time of remogliflozin etabonate and Metformin Hcl were found to be 5.493 min and 3.183 min respectively. The method has been validated for linearity, accuracy and precision. Linearity observed for remogliflozin etabonate 5-15 μg/ml and for Metformin Hcl 20-60 μg/ml. Developed method was found to be accurate, precise and rapid for simultaneous estimation of remogliflozin etabonate and Metformin Hcl in their Synthetic Mixture. The drug was subjected to stress condition of hydrolysis, oxidation, photolysisand Thermal degradation, the proposed method was successfully applied for thesimultaneous estimation of both the drugs in commercial Synthetic mixture.

Keywords: Remogliflozin Etabonate, metformin hcl, RP-HPLC, validation.