Abstract

FORCED DEGRADATION STUDIES OF IRBESARTAN AND ANALYSIS OF ITS FRAGMENTS

M. Mamatha Asha* and B. Sandhya

ABSTRACT

Forced degradation studies include the degradation of drug substances and drug product at conditions more severe than the accelerated conditions. The purpose of this study is to know the exact shelf life of the anti-hypertensive drug irbesartan under various conditions like ambient condition, humidity, temperature, photo light and analysis of its parameters as per ICH guidelines. The forced degradation studies were carried out on hydrolysing the drug substance within the sight of water, acid and base shows no significant change in the peak purity indicating that the API is stable and does not undergo any changes due to hydrolysis. The same observation was achieved in case of forced degradation by oxidation. The peak purity matches with the mother sample but on hydrolysis, acid and oxidation degradation IMPURITY-3 has been identified and on base degradation IMPURITY-A has been identified. The project will be further studied what kind of Impurity and how it was developed.

Keywords: Irbesartan, Degradation Studies, ICH guidelines.