Physico-chemical properties, analytical determinations and stability of sertaconazole nitrate.

Abstract

Sertaconazole nitrate, the nitrate salt of 7-chloro-3-[1-(2,4-dichlorophenyl)-2-(1H-imidazol-1-yl)ethoxy-methyl] benzo[b]thiophene (sertaconazole, FI-7045, CAS 99592-32-2), is a new azole antifungal, which has proved to have a wide spectrum and high activity. This paper describes its physico-chemical properties, structural identification including polymorphism, detection of impurities, determination of related compounds, separation, quantification and purity assays using high-performance liquid chromatography (HPLC) and quantitative assays specially elemental and functional analysis. Stability of sertaconazole nitrate in solid form under accelerated (light, humidity and temperature) and real time conditions and in suspension form at different pH values (acid and basic) was also studied. The results show that sertaconazole nitrate is extremely stable under all the conditions tested, both in solid and in suspension form. Sertaconazole nitrate in solid form packaged in tight sealed amber glass bottles was stable for over 5 years under normal storage conditions.