Development and validation of reversed phase HPLC method for determination of apremilast in bulk and pharmaceutical dosage form

Abstract

The present study describes a novel 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 1120LC Compact system with Binary gradient system connected to UV- Absorbance Detector. Acetonitrile: (30mM) Potassium dihydrogen phosphate buffer pH adjusted to 3.0 with o-phosphoric acid (60:40 v/v), and flow rate 1.0ml/min with an injection volume of 20 μL was selected as it gave sharp symmetric peak for APL with minimal tailing and with desired elution graph.The separation was carried out at a room temperature and the eluents were observed by UV - Vis detector set at 236 nm. The retention time of APR obtained was at 4.46 minutes. The calibration curve for APR was linear (r2= 0.995) over thetested concentration range of 10 - 60 μg/ ml with LOD and LOQ of 0.93 μg/ml and 2.82μg/ml respectively. A recovery of APR in tablet formulation was observed in the range of 98.40 -100.00 %. Thus the proposed method for APR was found to be feasible for the estimation of APR in bulk as well as pharmaceutical dosage form.