A NOVEL VALIDATED STABILITY INDICATING METHOD FOR QUANTIFICATION OF EMPAGLIFLOZIN IN BULK AND MARKETED FORMULATION BY HPTLC APPLYING EXPERIMENTAL DESIGN APPROACH

Abstract

For the purpose of analyzing empagliflozin, a stability indicating high performance thin layer chromatographic method was developed. This method was optimized using design of experiment. In order to optimize the process, independent variables such as the proportion of isopropyl alcohol in the mobile phase, the duration of time that the chamber was saturated and the distance of mobile phase travelled were considered. On an aluminum plate that had previously been coated with silica gel, development was carried out with the assistance of twin trough glass chambers in ascending lines. The findings from these studies led to the selection of a mobile phase that had a composition of ammonium acetate (2 %), triethylamine and isopropyl alcohol in the ratio of 4:1:5 (V/V/V), and this mobile phase was utilized in the process of method development using central composite design approach. The saturation time was established at 10 minutes, and the ultraviolet detection was performed at a wavelength of 237 nm. The value 0.82 was discovered to be the retention factor (Rf ) for empagliflozin. The method was linear, precise and accurate over the entire concentration range examined (100-600 ng band-1), along with correlation coefficient value of 0.992. The proposed method is quick and selective, and a straightforward method of sample preparation and analysis for empagliflozin in its bulk and commercially available dosage forms. The stability of the drug was tested under a variety of different stress conditions in accordance with ICH guidelines, and the results obtained from the force degradations indicate that the developed method is appropriate for stability studies.