Development and Validation of Spectrophotometric and Chromatographic Method for the Estimation of Apremilast in Bulk and Formulations

Abstract

Objective: Objective of the present analytical research work was to develop and validate Spectrophotometric method and High Performance Liquid Chromatographic method (HPLC Method) for the Apremilast bulk and tablets dosage form. Methods: A spectrophotometric method and a HPLC method have been developed and validated for estimation of APR in pharmaceutical oral dosage form. Method A (UV SPECTROMETRY Method): The stock and working standard solutions of the drugs were prepared in methanol. Standard solutions were scanned over the range of 400-200 nm in spectrum mode of spectrophotometer at medium scanning speed using UV spectrophotometer. The maximum absorbance for Apremilast was found at 230 nm. Method B (HPLC Method): The HPLC Method for Apremilast was developed using Cosmosil C18 (4.6mm x 250mm, Particle size: 5μm), as stationary particle, isocratic mode. Methanol: Water (80:20v/v) pH3 as mobile phase. Mobile phase was maintained at a flow rate of 0.8 ml/min and detection was carried out at 230 nm. Both the methods were validated in accordance with ICH guidelines Results: Apremilast was found to be linear in the concentration range of 2-10 μg/ml for spectrophotometric method and 10-50 μg/ml for HPLC method. Retention time was found to be 4.0 min for Apremilast. The amount of Apremilast in marketed formulation by spectrophotometric method was found to be 99.82 %, the amount of Apremilast in marketed formulation by HPLC method was found to be 99.98 %. Interpretation and Conclusion: Results of assay and validation study were found to be satisfactory. So, the methods can be successfully applied for the routine analysis of Apremilast.