Abstract

METHOD DEVELOPMENT AND VALIDATION OF FORCED DEGRADATION STUDIES OF APREMILAST BY USING UV SPECTROPHOTOMETRIC METHOD

*Syeda Kulsum, Dr. G. Vidya Sagar, Afreen Butul, Saba Fatima, MD Sami Uddin

ABSTRACT

Apremilast is a drug for the treatment of certain types of psoriasis and psoriatic arthritis. It may also be useful for other immune system related inflammatory diseases. The drug has maximum absorbance at 220nm. The optical characteristic of drug was found within Beer’s law limits 20-100 μg/ml, Correlation coefficient is 0.999. The drug sample was analyzed by UV spectroscopy using methanol as solvent and the average content of drug present in the formulation was found to be 99.7%. The force degradation studies of Apremilast tablet was done. Stress degradation performed by hydrolysis procedure under alkaline condition by using 0.1M NaOH was found to be 13.3%. Stress degradation by hydrolysis under acidic condition by using o.1M HCl and product degradation was found to be 8.2%. Dry heat induced degradation was done by using 800c temperature was found to be 14.5% for 26 hrs. Oxidative degradation was done by using hydrogen peroxide and product degradation was found to be 12.5%. Photolytic degradation was found to be 10.7% for 4hrs.

Keywords: Apremilast, UV Spectroscopy, Validation, Forced Degradation.