Research Article Stress Degradation Studies on Cetirizine Dihydrochloride and Development of Degradation Pathways

Cetirizine dihydrochloride, a nonsedative antihistaminic is subjected to different stress conditions like hydrolytic conditions (neutral, acidic, alkaline) oxidative and photolytic conditions according to ICH guidelines. The separation study has been carried out using HPLC and an analytical method has been developed to optimally resolve the drug peak and degradation methods. Drug undergoes extensive degradation (around 99%) in oxidative, neutral and hydrolytic conditions over 48 hrs. In photolytic conditions, degradation is around 30-50%, whereas in alkaline conditions, it undergoes insignificant degradation. The resulting degradation products DCZI-DCZ3 are isolated, purified and characterised by spectral analysis. In neutral and acidic hydrolytic conditions same degradation product is formed which is α-(4-chlorophenyl) benzyl alcohol, whereas in oxidative conditions it is characterised as 4chlorobenzophenone.Degradation pathways leading to these degradation products have also been proposed.