The present study describes a novel stability indicating Reversed Phase High-Performance LC method for the determination and estimation of Apremilast (APR) in bulk and pharmaceutical formulation. The chromatographic separation was carried out on Agilent technologies model SPD 20A prominence UV - Vis detector, utilizing eclipse XDB model C18 Column (based on 99.999% ultra high purity silica) 250 mm ×4.6 mm, 5 μ particle size, utilizing acetonitrile as mobile phase at flow rate of 1 ml/min with an injection volume of 20 μL was selected for this study. The separation was carried out at a room temperature and the eluents were observed by photo diode array detector set at 229 nm. The retention time of APR obtained was at 2.488 minutes. The calibration curve for APR was linear (r2= 0.9989) over the tested concentration range of 2 - 10 μg/ ml with LOD and LOQ of 0.003 μg/ml and 0.001μg/ml respectively. A recovery of APR in tablet formulation was observed in the range of 99.18 -101.61 %. Percentage assay of APR tablets (Otezla) and bulk drug was found to be 99.80 ± 0.002 and 99.90 ± 0.001 respectively. The stability of the method was demonstrated by forced degradation studies of drug in which it was degraded under conditions of hydrolysis acidic, alkaline, oxidation, photolytic and thermal stress as per ICH Q1A (R2) guidelines. Thus the proposed method for APR was found to be feasible for the estimation of APR in bulk as well as pharmaceutical dosage form.
