Kinetic Study of Hydrolytic degradation of Rivaroxaban by HPTLC

Abstract

The main objective of a research involved kinetic study of hydrolytic degradation of Rivaroxaban and validation of stability indicating HPTLC Method for estimation of rivaroxaban as per ICH guidelines.The chromatographic separation was carried on Merck TLC aluminium sheets of silica gel 60 F254 (10×10cm) with mobile phase of Acetonitrile: Ethyl acetate (3:7 v/v) with densitometric scanning at 249nm. Acceptable peak parameters were obtained at the retardation factor of about 0.75±0.02. The proposed method was validated according to ICH guidelines. The results were acceptable for linearity and range, accuracy, precision, robustness, detection limit and quantitation limit. During stress degradation study, it was observed that the rivaroxaban is more sensitive to hydrolytic conditions. Degradation product peak was well resolved when the sample exposed to alkali catalysed hydrolysis for 72 hrs. was spotted on TLC plate and studied by the developed method. Such a product peak was not observed at 48 hrs. exposure, though there was reduction in drug peak area. This prompted us to study degradation kinetics under alkaline hydrolytic conditions, and the results of the degradation kinetic study indicates that the reaction follows first order kinetics. Interestingly there was no product peak under acidic hydrolytic condition. Results of thermal, oxidative and photolytic degradation studies show reduction in drug peak area.The developed method describes simple, sensitive, and specific stability indicating HPTLC method for estimation of rivaroxaban. This optimised method can be considered as good alternative for routine analysis of the rivaroxaban stability.