DEVLOPMENT AND VALIDATION OF UV-SPECTROPHOTOMETRIC AND HPLC METHOD FOR APREMILAST IN BULK AND TABLET DOSAGE FORM

Hemaraj R. Patil*, Dr. S. T. Patil, V. H. Jain and Dr. S. P. Pawar

ABSTRACT

The aim of this research work was to develop simple, precise and rapid UV-Spectrophotometric and HPLC methods for analysis of Apremilast in Bulk and Tablet dosage form. UV-Spectrophotometric method was developed for the estimation of Apremilast in individual tablet dosage form. The proposed methods were applied for the determination of drugs in bulk and tablet dosage form. Determination of Apremilast was done by simple method. In this method, concentration was obtained by using the absorptivity values calculated for the drugs at wavelengths, 230 nm. A rapid and reliable HPLC method was developed and validated for estimation of Apremilast in bulk and tablet dosage form. Chromatographic separation was performed on Agilent C 18 (4.6 mm 250 mm i.d.), 5μm particle size in isocratic mode, using a mobile phase Acetonitrile: Water (70:30 v/v), pH 7. The retention time for Apremilast was found to be 4.92 min. The method was applied to marketed tablet formulations. The UV-Spectrophotometric method was found to be simple, economical and rapid as compared to HPLC. But, HPLC method was found to be more accurate, precise, robust and rugged. Both these methods can be used for routine analysis of Apremilast in Bulk and Tablet dosage form.

Keywords: Apremilast, UV-Spectrophotometric, HPLC.