RP-HPLC Method Development and Validation of Dissolution Method for Anticoagulant Dosage Form

Anticoagulants are a class of dosage forms employed in the management of thrombotic conditions, which prolong the clotting duration. This research aims to quantify Edoxaban in solid oral dosage forms. A dissolution method for Edoxaban tablets has been developed, employing USP Apparatus II (Paddle) at a speed of 50 rpm with 900 ml of phosphate buffer (pH 6.0) as the medium at a temperature of 37°C. Additionally, a reversed-phase liquid chromatographic method was established for the simultaneous quantification of Edoxaban using a C18 column, which utilizes isocratic elution with acetonitrile and Triethylamine buffer (pH 5.5) at a flow rate of 1 mL/min. The retention time was approximately 4 minutes, and quantification was performed at its λmax (290 nm).Validation data were collected, demonstrating that the dissolution methodology is accurate, precise, linear, and robust for the Edoxaban immediate release tablet. Therefore, the proposed RP-HPLC method is suitable for routine quality control analysis for release determination.