Development and Validation of Spectrophotometric Method for the Estimation of Edoxaban Tosylate Monohydrate in its Synthetic Mixture

摘要

ABSTRACT Edoxaban Tosylate Monohydrate (EXN) is oral anticoagulant drug indicated to reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) and for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). Sensitive and reproducible UV- Visible spectrophotometric method has been developed and validated for the estimation of Edoxaban Tosylate Monohydrate in its synthetic mixture. Methanol was used as a solvent. Developed method has been validated for linearity range, precision, accuracy, limit of detection, and limit of quantification as per ICH Q2(R1) guidelines. The method was found to be linear in the range of 5-25 μg/mL at λmax 289 nm and the regression coefficient value was found to be 0.9999. For Edoxaban LOD and LOQ values were found to be 0.654 μg/mL and 1.982 μg/mL. The method was successfully applied for estimation of Edoxaban Tosylate Monohydrate in its synthetic mixture and results were found to be in good agreement with the amount of Edoxaban Tosylate Monohydrate present in synthetic mixture. Keywords: Edoxaban Tosylate Monohydrate, UV-visible Spectrophotometric method, Validation