Development, validation and stability study of pediatric atenolol syrup.

ABSTRACT

Atenolol [4-(2-hydroxy-isopropylaminopropoxy)-phenylacetamide], is a cardioselective beta1-adrenergic receptor blocking agent prescribed for treatment of hypertension, angina pectoris and cardiac arrhythmias. However, most of these medicines are not formulated for easy or accurate administration to children. Atenolol is unstable in solutions and therefore the development of a liquid dosage form is a significant challenge. Studies showed that the degradation rate of atenolol is dependent on the temperature, indicating higher stability at 4 degrees C. Atenolol syrup is stable for 9 days, with acceptable apearance. A second order model adequately described atenolol decomposition when stored as syrup. A stability-indicating method was developed and validated in order to evaluate these studies.