Validating a Stability Indicating HPLC Method for Kinetic Study of Cetirizine Degradation in Acidic and Oxidative Conditions

Document Type: Research article

Authors

Department of Medicinal Chemistry, Faculty of Pharmacy and Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, Iran.

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 (r2 > 0.999) and the withinday
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.

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