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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. [ABSTRACT FROM AUTHOR]

A stability indicating reversed-phase high-performance liquid-chromatographic method for analysis of empagliflozin was developed and validated as per the ICH guidelines. Statistical design of experiment was applied for optimization, where independent variables used were methanol proportions in mobile phase and flow rate. Experiment was carried out on an analytical reversed phase column Cosmosil C18 (250 x 4.6 mm, 5 µm). Based on the results obtained from these studies, suitable mobile phase with appropriate composition was selected and utilized for method development applying DoE approach. The mobile phase used was methanol: water (85:15 V/V). The flow rate was set at 0.8 mL min-1 and UV detection was carried out at 225 nm. The retention time of empagliflozin was found to be 4.259 min. The lower solvent consumption along with the short analytical run time (≤05 minute) provides a cost effective and environment friendly chromatographic procedure. The measured signal was shown to be precise, accurate and linear over the concentration range tested (10-50 µg mL-1) with a correlation coefficient of 0.9999. Thus, the proposed methodology is rapid, selective and requires simple sample preparation steps and represents a good procedure for analysis of empagliflozin. Central Composite Design (CCD) was used for method development of empagliflozin. Two factors were selected with eight center points and response of empagliflozin was measured in terms of retention time which dependent on two factors namely, methanol content in mobile phase and flow rate. CCD was effective means in optimization of HPLC for analysis of empagliflozin in pharmaceutical formulation. The stability of the drug was exam- ined over different stress conditions as per International Conference on Harmonization (ICH) guidelines. Results obtained from the force degradation studies indicated that the developed method is appropriate for stability studies. [ABSTRACT FROM AUTHOR]