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

Introduction Edoxaban (EXN), chemically known as N'-(5-chloropyridin-2-yl)-N-[(1S,2R,4S)-4-(dimethylcarbamoyl)- 2- [(5-methyl-6,7-dihydro-4H- [1,3] thiazolo [5,4-c] pyridine-2-carbonyl)amino] cyclohexyl] oxamide, is an oral anticoagulant that acts as highly specific direct factor Xa inhibitor.1 In 2011, Japan approved EXN for prevention of venous thromboembolisms after total hip arthroplasty with no increased risk of bleeding.2,3 Food and Drug Administration approved EXN for the prevention of stroke and non central nervous system systemic embolism in patients having nonvalvular atrial fibrillation in 2015.4,5 So far EXN is not official in any pharmacopeias. Bathala et al.,6 analyzed EXN and its four metabolites in human plasma, urine and fecal samples, after oral administration of [14C] EXN to 6 healthy male subjects, by either high-performance liquid chromatography/tandem mass spectrometry or a liquid chromatography radiometric method. Application of the proposed method The aforementioned validation results indicated that the proposed method gave acceptable results. [...]application of the proposed method was checked by analyzing the EXN content in commercial tablet dosage forms.