Abstract

Rivaroxaban (RIV) is an oral anticoagulant that is the first available orally active direct inhibitor of factor Xa. This study focuses on a critical review of the mechanisms of action, characteristics, operations, physicochemical properties of RIV, and analytical methodologies to quantify the concentration of the agent in bulk, pharmaceutical formulations, dissolution media, and biological samples. The major analytical methodology for the determination of RIV is reverse-phase HPLC coupled with UV detection and LC-MS/MS. This technique is particularly beneficial to detect and analyze RIV in plasma samples. The methodologies published in literature until recently were tabulated and the sample preparation techniques prior to analyzes of the biological matrix were discussed. Based on this critical literature screening, it was concluded that the researchers may easily apply or modify the published methodologies depending on their purpose on further studies since the chemical and physical properties of RIV allows this agent to be extracted and analyzed by employing different analytical strategies.

摘要

利伐沙班 (RIV) 是一种口服抗凝剂，是第一个可用的口服活性 Xa 因子直接抑制剂。本研究的重点是对 RIV 的作用机制、特性、操作、物理化学性质以及量化试剂在散装、药物​​制剂、溶出介质和生物样品中的浓度的分析方法进行严格审查。测定 RIV 的主要分析方法是反相 HPLC 与 UV 检测和 LC-MS/MS 相结合。该技术特别有利于检测和分析血浆样品中的 RIV。直到最近才发表在文献中的方法被制成表格，并讨论了分析生物基质之前的样品制备技术。基于这一批判性文献筛选，