Novel Stability–Indicating Reverse‐Phase High‐Performance Liquid Chromatography Technique for Apremilast Quantification in Pharmaceuticals and Nanovesicular Systems: A Design of Experiment Approach

Abstract

An accurate and precise reverse‐phase high‐performance liquid chromatographic technique for apremilast (APR) quantification in bulk, commercial tablets, and formulated APR‐loaded nanoformulations was developed and validated by the design of the experiment approach in accordance with the International Conference of Harmonization guidelines. APR was separated by using formic acid buffer (0.1%; pH 3.2):methanol (40:60, v/v) as a solvent system with a flow rate of 1 mL/min and was detected at a wavelength of 230 nm with a retention time of 7.1 min. The central composite design was employed to optimize the developed analytical method. The calibration curve for APR was linear (r2 = 0.999), with a limit of detection of 0.5 µg/mL and a limit of quantification of 1.52 µg/mL, respectively. A recovery of APR in tablet and nanoformulation was observed in the 98.56%–99.32% range. Forced degradation studies revealed the stability of the proposed analytical method, as the APR peak remained unchanged under stress‐induced degradation experiments. Hence, the proposed chromatographic technique with a cost‐effective solvent system could be employed in the pharmaceutical industry for estimating APR in various formulations.