A simple HPLC-DAD method for determination of adapalene in topical gel formulation.

A simple stability indicating high-performance liquid chromatography method for the analysis of adapalene in pharmaceutical gel formulation is developed and validated. An isocratic separation is performed using a Merck RP-8 (150 mm × 4.6 mm i.d., particle size 5 m) column and a mixture of acetonitrile water (67:33, v/v, pH adjusted to 2.5 with phosphoric acid) as the mobile phase. The detection is achieved with a photodiode array detector at 321 nm. The specificity of the method is verified by subjecting both the reference substance and the pharmaceutical form to hydrolytic, oxidative, photolytic, and thermal stress conditions. There is no interference from the excipients of the formulation on the determination of adapalene in gel. The response is linear over the concentration range of 8.0-16.0 μg/mL (r > 0.999) with a limit of detection and quantification of 0.04 and 0.14 μg/mL, respectively. The mean recovery is 100.8%. The RSD values for the intra- and inter-day precision studies are < 1.2%. The method is validated by reaching satisfactory results for linearity, selectivity, specificity, precision, accuracy, robustness, and system suitability.