医薬品マトリックス中のアピキサバンの評価における現行分析法の環境効率

Apixaban (APX) prevents stroke and systemic embolism in patients with nonvalvular atrial fibrillation, as well as venous thromboembolism, and is marketed in tablet form.

This review provides an overview of analytical methods for evaluating APX in pharmaceutical matrices, with a focus on the eco-efficiency of green and white analytical chemicals. Studies published over the past decade were critically assessed to identify methodological trends and evaluate greenness using established assessment tools.

The manuscript presents more than 40 analytical methods from the last 10 years for the evaluation of APX in pharmaceutical matrices. More than 75% of them are HPLC, and the majority, approximately 44%, use acetonitrile as a solvent. All methods presented were evaluated for their greenness profile. On average, they presented two green quadrants according to the National Environmental Methods Index (NEMI), a score greater than 75 on the Analytical Eco-Scale (ESA) in 88% of cases, an Analytical GREEnness Metric (AGREE) score of approximately 0.64, and all obtained more than 60 points on the Blue Analytical Grade Index (BAGI). Although eco-efficient options for APX evaluation in pharmaceutical matrices exist, the choice must be aligned with the intended objective, analysis routine, team training, time, resources, and cost.

Therefore, continuous refinement of practices is essential to ensure that methods remain efficient, robust, and environmentally responsible.