Development and Validation of a Novel Stability Indicating UPLC Methodfor Dissolution Analysis of Bexarotene Capsules: An Anti Cancer Drug

Abstract

A novel stability indicating liquid chromatographic method for dissolution analysis of Bexarotene capsules, 75 mg has been developed and validated. Efficient chromatographic separation was achieved on a C18 column (50 mm × 2.1 mm, 1.7-μm particles) with a simple isocratic mobile-phase at a flow rate of 1.0 mL min−1. Quantification was achieved by use of ultraviolet detection at 260 nm. After the determination of the solubility the conditions selected were paddle at 50 RPM, with 900 mL of 0.5% HDTMA (hexadecyltrimethylammonium bromide) in 0.05 M phosphate buffer, pH adjusted to 7.5 with 1 N Sodium hydroxide at 37°C ± 0.5°C. Under these conditions the in vitro release profile of Bexarotene capsules, 75 mg shown good results. The drug release was evaluated by Reverse phase HPLC using mixture of Acetonitrile, water and trifluro acetic acid 70:30:0.1 (v/v/v). The method was validated for linearity, accuracy, precision, ruggedness, solution stability, mobile phase stability as per ICH guidelines to meet requirements for a global regulatory filing.