A Stability-indicating RP-HPLC Method for the Development and Validation of Edoxaban

Abstract

Anticoagulants represent a category of dosage forms utilized in the treatment of thrombotic disorders, which extend the clotting time. This study focuses on quantifying Edoxaban in solid oral dosage forms. A precise RP-HPLC method was established to ascertain the Edoxaban content using a specific stability-indicating approach. Edoxaban is effectively resolved using a C18 column with isocratic elution employing acetonitrile and Triethylamine buffer (pH 5.5) at a flow rate of 1 mL/min, with the peak appearing at a retention time of approximately 4 minutes and quantified at its λmax (290 nm). The method demonstrated accuracy and linearity across the concentration range of 14.91 µg/ml to 89.46 µg/ml of the test concentration. A forced degradation study was conducted to validate the specificity of the method, confirming degradation and establishing it as a stability-indicating method. The developed method has been validated in accordance with ICH guidelines and has been found to be satisfactory, precise, linear, and accurate. Consequently, the proposed RP-HPLC method is employed in routine quality control analysis for content determination. Edoxaban has significant role in preventing the sroke and systemic embolism in patients and availability of stability indicating method facilitate the Edoxaban medication to the patient rapidly and purest form.