STABILITY INDICATING ASSAY METHOD DEVELOPMENT AND VALIDATION OF EDOXABANTOSYLATE MONOHYDRATE: A COMPREHENSIVE STUDY INVOLVING IMPURITIES ISOLATION, IDENTIFICATION AND DEGRADATION KINETICS DETERMINATION IN VARIOUS CONDITIONS

Objective: State of the art, robust and environmentally benign stability indicating assay method (SIAM) has been developed for model drug Edoxabantosylate (EDO) Methods: Successful RP-HPLC chromatographic method was accomplished on a CHROMBUDGET^® 100-5-C18 column (250 mm × 4.6 mm, 5 μ) column using methanol and acetate buffer in the ratio of 53:47 having 2.9 pH and 10mM buffer strength. The degradation study was performed in the presence of various stressors, and SIAM develop was selective enough to discriminate the EDO peak with the peak of other degradation production (DP) with acceptable resolution. The degradation kinetics study and fragmentation pattern of isolated major DPs were carried out. Results: The developed SIAM validated as per ICH Q2(R1) guidelines. Two major DPs i.e. DP-I and DP-II, were isolated and characterized thoroughly. Furthermore, the reaction kinetics data revealed that EDO degradation was following first-order degradation kinetics. Conclusion: An extensive stress degradation study along with degradation kinetics, were performed. All probable degradation pathways were predicted by using LC-MS/MS and NMR data obtained by characterization of the isolated DPs.