Development and Validation of a Stability-Indicating LC Method for Determination of Bexarotene in Softgel Dosage Formulation

This study focuses on a novel liquid chromatographic approach that has been developed and approved for the quantitative determination of bexarotene (BXT), its potential impurities in drug substances and drug products. Chromatographic separation was developed on a Symmetry C8 (150 × 4.6) mm 5-µm column with a mobile phase containing an isocratic mixture of acetonitrile:DI water:glacial acetic acid (650:350:7.5) v/v/v at a flow rate of 1.2 mL min−1, and quantitation was carried out using ultraviolet detection at 262 nm for BXT and 290 nm for BHA with a column temperature of 35 °C. The resolution among butylated hydroxyanisole (BHA), BXT and its process-related impurity-A was found to be greater than 5. Regression analysis confers an R value (correlation coefficient) higher than 0.998 for BHA, BXT and impurity-A. The detection level for BXT impurities was found at a level below 0.03% (0.18 µg mL−1). The inter- and intra-day precisions for BHA, BXT and impurities were evaluated and found to have a %RSD of less than 3.0.