Stability-Indicating HPLC Method for Determination of Naftazone in Tablets. Application to Degradation Kinetics and Content Uniformity Testing

Abstract

A simple, sensitive, stability-indicating HPLC method was developed and validated for the quantitative determination of the vasoprotective drug, naftazone in presence of its degradation products. The analysis was carried out on a Nucleosil 100-5 phenyl column (250 mm × 4.6 mm, 5 μm) using a mobile phase consisting of methanol-0.02 M sodium dihydrogen phosphate mixture (60:40, v/v) of pH 6.0. The analyses were performed at ambient temperature with a flow rate of 1.0 mL/min and UV detection at 270 nm. The method showed good linearity over the concentration range of 0.1-10.0 μg/mL with a lower detection limit of 0.032 and quantification limit of 0.096 μg/mL. The suggested method was successfully applied for the analysis of naftazone in its commercial tablets. Moreover, it was utilized to investigate the kinetics of alkaline, acidic and oxidative degradation of the drug. The apparent first-order rate constants, half-life times, and activation energies of the degradation process were calculated. The pH-rate profile curve was derived. Furthermore, the proposed method was successfully applied to the content uniformity testing of naftazone tablets.