DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING HPTLC ASSAY METHOD OF REMOGLIFLOZIN ETABONATE IN BULK AND MARKETED FORMULATION

Remogliflozin Etabonate (RE) is the latest addition to the sodium-glucose transport proteins 2 inhibitor class of drugs recently approved in India to manage type 2 Diabetes Mellitus. Literature survey revealed that no high-performance thin-layer chromatographic (HPTLC) method had been reported to date for this drug. The present work describes the development and validation of an HPTLC method for RE. The chromatography was performed on pre-coated silica gel 60 F 254 plates using methanol: toluene: ethyl acetate (1:4:5) v/v/v as mobile phase. A thin layer chromatographic (TLC) scanner set at 228 nm was used to directly evaluate the chromatograms in reflectance/absorbance mode. The drug was satisfactorily resolved with R_f 0.45. The method was validated according to the International Council on Harmonization (ICH) guidelines. The calibration plot was linear between 50–300 ng/b and respectively. The accuracy and precision of the proposed method were evaluated by recovery studies and intra-day and inter-day precision studies, respectively. In stability testing, RE was found to be susceptible to alkaline degradation. Because the method could effectively separate the drugs from their degradation products, it may be used as a stability-indicating method.