Determination of Edoxaban in Bulk and in Tablet Dosage Form by Stability Indicating High-Performance Liquid Chromatography

Edoxaban is an orally active direct factor Xa inhibitor. The aim of the present study was to develop a stability indicating HPLC method for the quantification of edoxaban in bulk and in tablet dosage form.
Edoxaban was separated on Hypersil BDS C18 column (250 x 4.6 mm, i.d. 5µm) using 0.1M K2HPO4: Methanol (65:35, v/v) as an isocratic mobile phase at a flow rate of 1.0 ml/min. Detection was performed using photodiode array detector set at 245 nm. The chromatographic conditions were optimized. The method was validated as per the guidelines given by International Conference on Harmonization guidelines.
Edoxaban was eluted at 3.785 min with a total run time of 6 min. The calibration curve was found to be linear over the concentration range of 5–200 μg/ml. Limit of detection and limit of quantification for edoxaban are 0.209 µg/ml and 0.698 µg/ml, respectively. The intra- and inter-day precision values were ≤0.710% and the accuracy ranged from 99.824-100.720%. Besides, all the validation results were within acceptability criteria of general assay. The stability indicating nature of the method was established by subjecting the edoxaban to stress conditions such as acid and base hydrolyses, oxidative, photo- and thermal degradations. The degraded products formed in all stress conditions were resolved successfully from the edoxaban.
The developed and validated method is suitable for the determination of edoxaban in bulk and in commercial tablet dosage form.