A New Stability Indicating RP-HPLC Method for the Determination of Apremilast-An Antirheumatic Drug

A novel and simple reverse phase liquid chromatographic method has been established for the determination of Apremilast in pharmaceutical dosage forms. Apremilast is used to treat psoriatic arthritis. The proposed work was performed on Shimadzu Model CBM-20A/20 Alite with Intersil ODS3 C₁₈ column (250 mm × 4.6 mm i.d., 5 μm particle size). A mixture of 0.1% acetic acid and acetonitrile was used as mobile phase in this method with flow rate 0.8 ml/min (UV detection at 203 nm) and the method was validated as per ICH guidelines. The linear regression equation was found to bey = 78597x - 14159 with correlation coefficient 0.9999. Forced degradation studies were performed by exposing the drug Apremilast to acidic, alkaline, oxidation and thermal stress degradations. The proposed RP-HPLC method was found to be robust and specific and this method is suitable for the assay of pharmaceutical dosage forms as well as kinetic studies.