诊断为下肢有症状的外周动脉疾病(PAD)的患者患主要血管事件的可能性更高。最近,FDA已批准阿司匹林(ASP)和利伐沙班(ROX)的联合治疗,以减少(PAD)患者的急性肢体缺血和其他合并症。在三种简单而准确的分光光度技术(双波长(DW),用于同时检测和定量纯形式的ASP和ROX的比率差(RD)和导数比(1DD),实验室合成混合物和生物流体。我们的方法涉及仔细的参数优化,包括溶剂选择,样品体积,和仪器设置,以减少分析对环境的影响。对于纯活性药物成分,所获得的准确度回收率百分比在98-102%之内,对于药物制剂和生物学测定,为90-110%。进行了综合评估,以比较三种方法的易用性,线性度灵敏度,条件,和限制。通过分析实验室合成混合物来评价所提出的方法的特异性。根据ICH指南对建议的分光光度法进行了验证,以确认有效性。此外,我们进行了统计学分析,以比较从建议方法获得的结果和从官方方法获得的结果,它们在准确性和精确性方面与零假设一致.此外,使用分析绿色计算器对所开发方法的环境可持续性进行了全面评估,AGREE算法。选择的药物可以有效地,通过建议的方法在药物和生物基质中进行安全和经济地分析,没有预处理或初步分离步骤,从而提高了它们的绿色水平。
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.