Estimation of Apremilast in Bulk and Pharmaceutical Dosage Form by Stability Indicating High Performance Thin Layer Chromatographic Method

Abstract

The goal of this work is to develop and validate an accurate high-performance thin-layer chromatography (HPTLC) method for measuring Apremilast, it is an anti-psoriatic drug. TLC aluminum plates coated with silica gel 60F-254 as the stationary phase and a solvent system consisting of Toluene, Methanol, Triethanolamine (9:1:0.1, v/v/v) are used in this procedure. The densitometric study of the Apremilast chemical is carried out in absorbance mode at 229 nm, and its Rf value is 0.34. Within the 200–1600 ng/spot concentration range, the calibration plots show a high linear correlation for Apremilast; the quantification and detection limits are 39.84 and 120.72 ng/spot, respectively. Furthermore, Apremilast's stability is assessed using this HPTLC approach in relation to a range of circumstances, including UV radiation degradation, chemical oxidation, dry heat degradation, and acid and alkali hydrolysis. The validation of the approach covers characteristics such as linearity, accuracy, precision, and robustness, demonstrating its effectiveness in the analysis of Apremilast in tablet and bulk medication forms. To sum up, this study presents a robust and efficient HPTLC method for determining Apremilast which can be used as an important quality control tool in the pharmaceutical industry.