Innovative green stability-indicating HPLC method coupled with fluorescence detection for determination of antidiabetic agent canagliflozin

Abstract

This study exhibits a sustainable, easy, and reliable stability indicating HPLC approach utilizing fluorometric detection for quantification of canagliflozin (CANA) in the presence of its hepatotoxic oxidative degradation product (OXD). The chromatographic separation was accomplished using Symmetry® C18 column (3.5 μm, 4.6 × 100 mm). The mobile phase consists of 0.1 M phosphate buffer pH 2 and ethanol (40:60 v/v) pumped at a flow rate of 1.0 mL/min throughout the run. The eluted peaks were monitored by the fluorescence detector, and the chromatogram was extracted at emission wavelength of 410 nm for CANA and OXD after excitation at 290 nm which was suitable for both CANA and OXD. Performance of the suggested approach was assessed in accordance with ICH guidelines for linearity, accuracy, precision, robustness, detection, and quantitation limits. Linear relationship was achieved in the range of 0.50–10.00 μg/mL and 0.10–2.00 μg/mL for CANA and OXD, respectively with correlation coefficient 0.9999 for both components. The validated method was effectively utilized for the analysis of CANA in its pure form and drug tablets. The environmental sustainability of the suggested approach was evaluated and validated using various tools, including the analytical eco-scale, the Green Analytical Procedure Index (GAPI), and AGREE. Additional applications were employed to evaluate the ideas of 'blueness' and 'whiteness' through the newly developed Blue Applicability Grade Index (BAGI) and Red-Green-Blue 12 (RGB 12) algorithms. The elevated BAGI score (85) signified exceptional applicability, while the RGB12 score (92.2) verified the cost-effectiveness and sustainability of the used approach.