Method Development and Validation for the Assay of the Anticoagulant dosage form by HPLC

Anticoagulants are class of dosage form used in treatment of thrombotic disorders, which prolong the clotting time. This study includes quantifying Edoxaban in solid oral dosage form. An accurate RP-HPLC method was developed to determine Edoxaban content with specific stability indicating method. Edoxaban well resolve with C18 column using isocratic elution with acetonitrile and Triethylamine buffer (pH 5.5), at a flow rate of 1 mL/min appeared at retention time about 3.5 min and was quantified at its λ_max (290nm). It exhibited a accuracy and linearity over the concentration range of 14.910µg/ml to 89.460µg/ml of the test concentration. Forced degradation study was performed to prove the specificity of the method and degradation was achieved and proven stability indicating method. The developed method has been validated inline to ICH guidelines and found to be simple, precise, linear and accurate. Thus the proposed RP-HPLC method was used in routine quality control analysis for content determination.