Selective determination of diclazuril in the presence of its degradation products.

Abstract

A simple stability-indicating high-performance liquid chromatographic method was developed and validated for the determination of diclazuril (DIC) in the presence of its induced degradation products. The drug was subjected to stress stability study including acidic, alkaline, photolytic, thermal and oxidative stress conditions, and the stressed samples were analyzed by the proposed method. The developed method utilized a C18 column (250 × 4.6 mm, i.d., 5 μm) in an isocratic separation mode with mobile phase consisting of acetonitrile and 0.2% phosphoric acid at a flow rate of 1.2 mL/min with UV-detection at 275 nm. The proposed method was validated according to the International Conference on Harmonization guidelines. The method was applied in short term and accelerated stability studies for determination of the DIC in bulk powder and in its pharmaceutical formulation.