Stress degradation of Lisinopril as per ICH Guidelines & Characterisation

Abstract

Lisinopril an antihypertensive drug was subjected to stress degradation, since the drug is photosensitive undergo hydrolysis and oxidized in presence of oxygen. Hence the objective of the study was to stress degrade Lisinopril & to find out the pathway for stress degradation of Lisinopril. Stress testing methods are screening methods to be used to understand the degradation chemistry of a drug. Lisinopril was subjected to stress degradation under different conditions recommended by International Conference on Harmonization (ICH). The chromatographic separation of Lisinopril & its degradation products was done on C18 column & mobile phase was mixture of Methanol & Water in ratio 80:20, pH 3.5 adjusted with orthophosphoric acid at a flow rate of 1ml/min using UV detector with ?max 220nm. The quantification & characterizations of degraded products were carried out by UV, IR spectroscopy & HPLC. The mechanism of degradation was confirmed by GC-MS fragmentation pattern.