Abstract
Rivaroxaban is a potent selective oral direct factor Xa inhibitor, which undergo hepatic first pass metabolism and high oral bioavailability. According to ICH guidelines, the major factors that contribute in degradation of a drug product comprise of temperature, time, photo degradation, pH variation (high and low), acid/base stress testing and/or with humidity. An attempt was made to examine and calculate the quantity of drug in the presence of degradation products by UV-Vi spectroscopy method. According to the WHO, the official assay limit of the content should not less than 97% and not more than 101.05% of labelled amount of Rivaroxaban. The results of experiment revealed that Rivaroxaban degrade much especially on exposure to UV light and heat but do not degrades in basic medium whereas slight degradation occurs in acidic medium.
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