How to Cite: Kolsure, A., Soni, R., & Bhat, M. (2022). Development and validation of reversed phase HPLC method for determination of apremilast in bulk and pharmaceutical dosage form. International Journal of Health Sciences, 6(S2), 9484–9493. https://doi.org/10.53730/ijhs.v6nS2.7491 International Journal of Health Sciences ISSN 2550-6978 E-ISSN 2550-696X © 2022. Manuscript submitted: 27 March 2022, Manuscript revised: 18 April 2022, Accepted for publication: 9 May 2022 9484 Development and validation of reversed phase HPLC method for determination of apremilast in bulk and pharmaceutical dosage form Anuja Kolsure Research Scholar, Faculty of Pharmacy, (B. R. Nahata College of Pharmacy), Mandsaur University, Mandsaur -458001 (M.P), India Corresponding author email: anuja.kolsure63@gmail.com Rupesh Soni Faculty of Pharmacy, (B. R. Nahata College of Pharmacy), Mandsaur University, Mandsaur – 458001 (M.P), India Mahesh Bhat Nuper Therapeutics, A division of Jain Pharmaceuticals, Pune - 411045 (M.H), India. 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. Keywords---apremilast, RP-HPLC, validation.