COMPARISON OF ACID DEGRADANT PRODUCT WITH METABOLIC PATHWAY OF REMOGLIFLOZIN ETABONATE IN DEVELOPED AND VALIDATED RP-HPTLC METHOD

Abstract

Forced degradation studies in tablet and bulk formulations of remogliflozin etabonate have been developed using a precise and sensitive high performance thin layer chromatographic method. The silica gel RP-18 F254S plates were used as the stationary phase and ACN: water: ammonia solution (8:2:0.5 V/V/V) was used as the mobile phase for estimation. The proposed method was successfully validated, showing the Rf of the drug as 0.72 at 229 nm. The method was observed to be linear in the range of 500-3000 ng band-1 and then degradation was estimated by forced degradation pathway. In the forced degradation studies, the drug was found to be highly susceptible to both acid and base, including oxidative conditions, providing an active metabolite when remaining in contact in stressed conditions for a short time (30 min), while in longer duration (36 h), the drug provided another metabolite which on characterization was found to be inactive and predicted to be reported in the metabolic pathway