Eco-Friendly Capillary Electrophoresis Method for the Quantification of Apixaban in Oral Dosage Form

Abstract

The present work describes, for the first time, an eco-friendly capillary zone electrophoresis (CZE) methodology for determining apixaban (APX), an oral anticoagulant. Separation was carried out using a fused silica capillary with an applied voltage of 20 kV and hydrodynamic injection for 5 s at 50 mbar. The electrolyte system consisted of 50 mM sodium borate at pH 8.0. The method was validated as recommended by ICH, establishing selectivity, linearity, precision, accuracy, and robustness. The analytical procedure was linear in the range of 10–125 µg mL−1 (r = 0.999). The limits of detection and quantification were determined to be 1.77 µg mL−1 and 5.37 µg mL−1, respectively. Precision was evaluated by relative standard deviation (RSD), with an intra-day RSD (n = 6) of 0.96% and an inter-day RSD (n = 18) of 4.42%. The average recovery rates for the pharmaceutical samples were excellent, ranging from 98.03% to 101.01%, with an RSD of 1.51%. Moreover, the green profile of the method was evaluated using the National Environmental Methods Index (NEMI), Analytical Eco-Scale, Green Analytical Procedure Index (GAPI), and Analytical GREEnness Metric (AGREE) assessment tools. The results suggest that the CZE method aligns with the principles of green chemistry, offering a greener alternative for the routine analysis of APX quality control. Also, the method presents a low-cost analysis, using fewer organic solvents and minimizing waste generation compared to techniques commonly used in routine analysis.