title: Validating a stability indicating HPLC method for kinetic study of cetirizine degradation in acidic and oxidative conditions.
abstract: A stability indicating High-Performance Liquid Chromatography (HPLC) method was validated and used to study the degradation of cetirizine dihydrochloride in acidic and oxidative conditions. The separation was carried out on a Symmetry C18 column and a mixture of 50 mM KH2PO4 and acetonitrile (60:40 v/v, pH = 3.5) was used as the mobile phase. The method was linear over the range of 1-20 μg/mL of cetirizine dihydrochloride (r(2) > 0.999) and the within-day and between-day precision values were less than 1.5%. The results showed that cetirizine dihydrochloride was unstable in 2 M HCl and 0.5% H2O2. The kinetics of the acidic degradation showed a pseudo-first-order reaction in the temperature range of 70-90°C. In addition, the kinetics of hydrogen peroxide mediated degradation was pseudo-first-order in the temperature range of 50-80°C.
authors.affiliation: Department of Medicinal Chemistry, Faculty of Pharmacy and Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Effat
authors.initials: E
authors.lastname: Souri
authors.forename: Ali
authors.initials: A
authors.lastname: Hatami
authors.forename: Nazanin
authors.initials: N
authors.lastname: Shabani Ravari
authors.forename: Farhad
authors.initials: F
authors.lastname: Alvandifar
authors.forename: Maliheh
authors.initials: M
authors.lastname: Barazandeh Tehrani
keywords: Cetirizine; Degradation; High-Performance Liquid Chromatography (HPLC); Kinetics; Stability