Abstract

STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF EDOXABAN BY UV SPECTROMETRIC METHOD

*D. K. Shanthi Priya, K. Deepika, Ch. Nikhitha, C. Sahasra and D. Phani Raja

ABSTRACT

The analysis of Edoxaban was achieved by using a double beam UV-visible spectrophotometer. The linearity was checked in different concentrations and Beer’s law was obeyed in the concentrations range of 2-10μg/ml for Edoxaban. The slope, intercept, and correlation coefficient values of are 0.025, 0.033, and 0.999 respectively. The precision studies were carried in terms of intraday, Interday, and repeatability. The percentage relative standard deviation (%RSD) values were found to be less than 2, which indicates that the method is precise. The recovery studies were carried out to ensure the reproducibility and reliability of the methods by adding a known amount of standard drugs and analysis was carried out as per formulation procedure. The recovery values were within the limits indicating that the method is accurate The robustness and ruggedness were carried out and were found to be within the limits. LOD and LOQ were carried out according to ICH guidelines and were found to be 0.110484 and 0.3348. In order to test the appropriateness of the developed method to the pharmaceutical formulation, an assay of Edoxaban tablets was performed at working concentration. Acid hydrolysis, alkaline hydrolysis, neutral hydrolysis, photolytic degradation, degradation under dry heat, and oxidative hydrolysis were performed for Edoxaban and the drug stability 9-24% was found to be 100%.

Keywords: Edoxaban, Recovery, Accuracy, Precision, Stability studies.