Stability Indicating HPLC Method for the Estimation of Deflazacort in Bulk and Pharmaceutical Dosage Forms

Abstract

A simple, precise and accurate Stability indicating high performance liquid chromatography method was developed and validated for the determination of Deflazacort in bulk and pharmaceutical dosage form. Deflazacort is useful for the treatment of Duchenne muscular dystrophy, its necessary evaluate the quality control of raw material used in the production. Deflazacort was exposed to acid, alkali and water hydrolysis, oxidation effect by hydrogen peroxide, thermal (dry and wet heat) and photolytic conditions. Drug was found to be stable under thermal conditions and photolytic conditions, but substantial degradation was observed under acid, alkali hydrolysis and oxidative conditions. Drug and its degradation products was achieved on an Kromasil 100-5-C18 column (300 cm × 3.9 mm) 5 μm column with isocratic flow. The mobile phase at a flow rate of 1.0 mL min−1, consisted of 20mM potassium phosphate buffer (pH 6.2)  and acetonitrile (50:50, v/v). The UV detection was carried out at 266 nm. A linear response was observed in the concentration range 20–100 μg mL−1. The retention time for Deflazacort was found to be 5.617 min. Limit of detection and limit of quantitation for Deflazacort were 4.74 and 14.37 μg mL−1 respectively. The method was successfully validated in accordance to ICH guidelines Q2 (R1) acceptance criteria for specificity, linearity, accuracy, precision, robustness, ruggedness and system suitability. The greenness of method was evaluated by using software tool AGREE: Analytical Greenness Calculator version 0.5. The analytical greenness score of the proposed method was found to be 0.60.