A Validated Derivative Spectroscopic Method for Estimation of Apremilast in Bulk Drug and Formulations

For the estimation of Apremilast, a straight forward, accurate, exact and stability-indicating Derivative Spectroscopy approach has been established. The Linearity range of the Apremilast at 287nm, over a concentration range of 4-40 µg/ml, (Beer Lambert linearity range) was discovered with a strong correlation coefficient, r2 = 0.996. Several validation factors were used to verify the accuracy, sensitivity and precision of the suggested spectrophotometric approach. Therefore, it is safe to use this method for routine Apremilast quality control analysis.