A Validated High Performance Liquid Chromatographic (HPLC) Assay for Nitazoxanide in Bulk and in Pharmaceutical Formulations

Abstract

Nitazoxanide, 2- [(5-nitro-1, 3-thiazol-2-yl) carbamoyl] phenyl] ethanoate (NTZ) is a new broad-spectrum, antiparasitic drug. The acid, alkaline and hydrogen peroxide oxidative degradation were studied in order to analyze nitazoxanide in the presence of its degradation products using high performance liquid chromatographic assay. The liquid chromatographic separation was achieved using two columns namely the solid core Poroshell 120 EC-C18 (4.6x 100mm, i.d. particle size, 2.7μm) and the fluorinated Pursuit 5PFP (4.6x150mm, i.d. particle size, 5μm), and a mobile phase composed of acetonitrile: water (90:10 v/v, pH 2.5 using glacial acetic acid and triethylamine) delivered at a flow rate 0.3mL min-1. The analyte(s) were detected using a UV detector set at 320 nm. The linearity of the proposed method was in the range of 20-200 μg mL-1 (r=0.9996) and (r=0.9998) using Poroshell 120 EC-C18 and Pursuit 5PFP columns, respectively. The proposed methods were validated in terms of accuracy, selectivity, sensitivity and precision for the analysis of nitazoxanide in bulk form and in pharmaceutical formulations. The degradation products produced from the forced stress tests studies did not interfere with the analysis of nitazoxanide. This indicates that the proposed methods are stability- indicating assays and are suitable for the determination of nitazoxanide in quality control laboratories. Keywords: Drug analysis, nitazoxanide, HPLC, stability- indicating assay.