Spectrophotometric resolution for quantitative analysis of aspirin and rivaroxaban combination therapy in biological fluids using simple and eco-friendly procedure

Abstract

Abstract Patients diagnosed with symptomatic peripheral artery disease (PAD) in the lower extremities have a higher likelihood of suffering from major vascular events. Recently, FDA has approved the combination therapy of aspirin (ASP) and rivaroxaban (ROX) to reduce acute limb ischemia and other comorbidities in (PAD) patients. Zero order and ratio absorption spectra were employed in three simple and accurate spectrophotometric techniques (dual wavelength (DW), ratio difference (RD) and derivative ratio (1DD) for concurrent detection and quantification of ASP and ROX in their pure forms, lab synthetic mixtures and in biological fluid. Our approach involves careful parameter optimization, including solvent selection, sample volumes, and instrumental settings, to reduce the analysis environmental impact. The acquired recovery percentages of accuracy were within 98–102% for pure active pharmaceutical ingredients and 90–110% for pharmaceutical formulations and biological determinations. A comprehensive assessment was done to compare the three methods regarding their ease of use, linearity, sensitivity, conditions, and limitations. The specificity of the proposed methods was evaluated by analyzing the lab synthetic mixtures. The suggested spectrophotometric methods were validated in compliance with ICH guidelines to confirm the validity claims. Also, statistical analysis was done to compare the outcomes obtained from the suggested methods with those obtained from the official ones and they agreed with null hypothesis regarding accuracy and precision. Furthermore, a comprehensive assessment of the environmental sustainability of the developed method was carried out using the Analytical Greenness Calculator, AGREE algorithm. The selected drugs can be efficiently, safely and economically analyzed by the suggested methods in pharmaceutical and biological matrices with no pretreatment or preliminary separation steps and thereby increasing their greenness level.

Keywords

• Aspirin
• Rivaroxaban
• Peripheral artery disease (PAD)
• Biological fluid
• Greenness assessment