Asian Journal of Pharmaceutical Analysis

Irbesartan is an antihypertensive drug, undergoes hepatic first pass metabolism and low oral bioavailability. According to ICH guidelines factors which cause forced degradation of a drug product comprise of temperature, time, photo degradation, pH variation (high and low), acid/base Stress testing and/or with humidity. UV-Vi spectroscopy method was designed to examine and calculate the quantity of drug in the presence of degradation products. According to the WHO, the official assay limit of the content should not less than 99%and not more than 101% of labelled amount of Irbesartan. From our experiment we can conclude that Irbesartan degrades most when exposed to UV light and heat but do not degrades in basic medium whereas slight degradation occurs in acidic medium.