An Analytical, accurate, precise, efficient and simple RP-HPLC method has been developed and validated for the determination of Edoxaban in bulk and marketed pharmaceutical dosage forms. The mobile phase used for the chromatographic runs consisted of Acetonitrile and Phosphate buffer (0.01M, pH-3.2) in the ratio of 30:70% v/v. The Chromatographic Separation was achieved on a Symmetry C18 ODS (4.6mm × 250mm) 5µm particle size column using isocratic mode. Drug peak was well separated and were detected by a UV detector at 246 nm. The developed method was linear at the concentration range 6–14 μg/ml for Edoxaban. The method has been validated according to ICH guidelines with respect to system suitability, specificity, precision, accuracy and robustness. Edoxaban Limit of detection (LOD) and Limit of Quantification (LOQ) were 0.487μg/ml and 1.477μg/ml respectively. As a result, the suggested method with excellent specificity, accuracy, precision, linearity and robustness as well as economical was useful for the regular quality control analysis of Edoxaban in bulk and pharmaceutical dosage forms.
A. Muralidhar Rao, A. K. Likhitha Priya, Madam Allaji, Krishna Priya, Mehmood Hasan, Bhukya Vijay
Edoxaban, RP-HPLC, Accuracy, Precision, Robustness, ICH Guidelines.
