As an anticoagulant, Edoxaban (EDX) is a high risk drug that may cause a life-threatening bleeding. Also, it is prescribed as a chronic therapy for atrial fibrillation and venous thromboembolism patients. They are special population that needs appropriate care and optimum dosing of EDX. Hence, its monitoring in the patient plasma is fundamental, especially in emergency and special circumstances. However, such patient mostly receives many drugs of different pharmacological classes, side by side with EDX. This study represents the first attempt to quantify EDX in plasma without interference of the plasma matrix or concomitant medications. An accurate RP-HPLC-DAD method was developed for this purpose. It succeeded to monitor EDX level, selectively, without interference of plasma matrix or 16 of its frequently co-administered drugs. All drugs were extracted from plasma samples by protein precipitation followed by evaporation and concentration. EDX was well resolved from the co-administered drugs on C₈ column using linear gradient elution of methanol and phosphate buffer (pH 4), at a flow rate of 1 mL/min. EDX appeared at retention time 9.6 min and was quantified at its λ_max (290 nm). It exhibited a linear response over the concentration range of 0.15–2.2 μg/mL plasma which covers the reported therapeutic concentration. The suggested method fulfilled the US FDA guidelines for bioanalytical method validation. The developed method is fully discussed in comparison with the reported techniques. An in vivo study was performed to ensure applicability of the method on real plasma samples without interference from plasma matrix, co-administered drugs or the expected metabolites. It presented a unique selectivity of the method that guarantees accurate laboratory monitoring of EDX in plasma in almost all combined treatments including such novel oral anticoagulant drug.

作为抗凝剂，依多沙班（EDX）是一种高风险药物，可能会导致生命危险。另外，它被规定为房颤和静脉血栓栓塞患者的慢性疗法。他们是特殊人群，需要适当的护理和EDX的最佳剂量。因此，对患者血浆的监测至关重要，特别是在紧急情况和特殊情况下。但是，这类患者大多与EDX并用许多不同药理学类别的药物。这项研究代表了对血浆中EDX进行定量而又不干扰血浆基质或伴随药物的首次尝试。为此目的，开发了一种精确的RP-HPLC-DAD方法。它成功地选择性监测了EDX的水平，而没有干扰血浆基质或它的16种常用药物。通过蛋白质沉淀，然后蒸发和浓缩从血浆样品中提取所有药物。从C的共同给药药物可以很好地解决EDX₈柱使用甲醇和磷酸盐缓冲液（pH 4）的线性梯度洗脱，流速为1 mL / min。EDX出现在保留时间9.6分钟，并在其λ定量_最大（290 nm）。它在0.15–2.2μg/ mL血浆浓度范围内表现出线性响应，覆盖了报道的治疗浓度。建议的方法符合美国FDA的生物分析方法验证指南。与已报道的技术相比，已充分讨论了所开发的方法。进行了一项体内研究，以确保该方法对实际血浆样品的适用性不受血浆基质，共同给药药物或预期代谢产物的干扰。它提供了该方法的独特选择性，该方法可确保几乎所有联合治疗（包括此类新型口服抗凝药）中的血浆中EDX的准确实验室监测。