DEVELOPMENT AND VALIDATION OF STABILITY INDICATING DENSITOMETRIC METHOD FOR ESTIMATION OF APREMILAST IN BULK DRUG AND TABLET DOSAGE FORM

The current work describes development and validation of a simple, accurate and precise stability-indicating high performance thin layer chromatographic (HPTLC) method for determination of Apremilast as bulk drug and in tablet dosage form. As stability testing is major step in the development of new drug as well as formulation, stress degradation studies were carried out according to ICH guidelines. Apremilast was found susceptible to all the analyzed stress conditions except photolysis. The separation was performed on pre-coated silica gel 60 F₂₅₄ plates (10 cm×10 cm) utilizing Toluene: Ethyl acetate (5: 5, v/v) as mobile phase with densitometric scanning at 230 nm. The retention factor was found to be 0.53 ± 0.02.Results were found to be linear in the range 100-600 ng band^-1. The developed method has been effectively applied for the drug estimation in tablet dosage form. The % drug content was found to be 100.03. The method was found to be precise as % R.S.D. values were less than 2. The developed method is stability indicating and can be successfully employed for quantification of drug in tablet dosage form. The results clearly indicated that there was no interference of the related substance for Apremilast which demonstrated that the developed method was stability-indicating and can be used for drug stability studies and quality control monitoring of Apremilast.