Development of
a Green Stability indicating HPLC Method for Quantification of genotoxic impurities
of Bexagliflozin and LC-MS/MS Profiling of its Degradation Products
Govindarao Yedlapalli, Nagineni Sudarshan Rao, Pavani Peddi, Venkata Swamy Tangeti
and Phani R.S.CH
Res. J. Chem. Environ.; Vol. 29(8); 11-20;
doi: https://doi.org/10.25303/298rjce011020; (2025)
Abstract
The stability and purity of pharmaceutical compounds are crucial for ensuring drug
efficacy and patient safety. Bexagliflozin, which is a sodium-glucose cotransporter
2 inhibitor, is applied to improve glycemic control in type 2 diabetes mellitus.
The literature suggests a robust analytical method for its quantification and stability
assessment. Hence, this study intended to propose a stability-indicating HPLC method
for the separation, identification and quantification of Bexagliflozin and its impurities
under various stress conditions. The developed method was validated and exhibited
high selectivity and resolution (Rs > 2) between Bexagliflozin and its impurities.
The calibration curve demonstrated excellent linearity within the concentration
range of 8–56 μg/mL for Bexagliflozin and 0.08–0.56 μg/mL for its impurities with
a correlation coefficient exceeding 0.9997. Accuracy was verified through recovery
studies, yielding mean recoveries of 99.36% for Bexagliflozin and 99.20–100.36%
for its impurities.
Structural elucidation of these degradation products was performed using mass spectrometry,
revealing key fragmentation patterns. The proposed method successfully distinguished
degradation pathways. Hence, we concluded that the developed HPLC method is a reliable
and effective tool for the quantification and stability assessment of Bexagliflozin.
The greenness of the method was evaluated using GAPI (Green Analytical Procedure
Index) and AGREE (Analytical GREEnness) tools, confirming that the technique can
significantly reduce the usage of hazardous solvents. The identification of DPs
provides critical insights into Bexagliflozin’s stability profile that facilitates
its safe and effective therapeutic use.
