Development and validation of a stability-indicating RP-HPLC assay method and stress degradation studies on Dapiprazole

Abstract

Dapiprazole (DPZ) was subjected to different stress conditions prescribed by the International Conference on Harmonization. A stability-indicating high-performance liquid chromatography method was developed for the analysis of the drug in the presence of its degradation products. The degradation was found to occur in hydrolytic, and to some extent, photolytic conditions, however, the drug was stable to oxidative and thermal stress. The drug was particularly labile under neutral and alkaline hydrolytic conditions. The assay was involved an isocratic elution of DPZ in a Kromasil 100C18 column using a mobile phase composition of water (pH 6.5, 0.05%, w/v, 1-heptane sulfonic acid) and acetonitrile (40:60, v/v). The flow rate was 0.8 mL/min and the detection was conducted at 246 nm. The assay method was found to be linear from 5 to 30 µg/mL. The method was validated for linearity, range, precision, accuracy, specificity, selectivity, limit of detection and limit of quantitation.