Stress degradation of Lisinopril as per ICH Guidelines & Characterisation
DOI:
https://doi.org/10.7439/ijapa.v4i2.81Keywords:
Aging, Reactive oxygen species, Antioxidant enzymes, Oxidative damage, Gelam honeyAbstract
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 and 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 and its degradation products was done on C18 column and mobile phase was mixture of Methanol and 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 and characterizations of degraded products were carried out by UV, IR spectroscopy and HPLC. The mechanism of degradation was confirmed by GC-MS fragmentation pattern.Downloads
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