Determination of sertaconazole nitrate, a new imidazole antifungal, by high-performance liquid chromatography

A high-performance liquid chromatographic method is developed for the determination of bulk sertaconazole nitrate and related compounds (potential impurities and degradation products) as well as a sertaconazole nitrate cream formulation. A 10-microns Spherisorb CN column is used along with a mobile phase consisting of acetonitrile and aqueous 0.01 M sodium phosphate (37:63, v/v). The sertaconazole nitrate peak is monitored at a wavelength of 260 nm; the retention time being 19.3 min. The detector response for sertaconazole nitrate is linear over the concentration range from 64 to 96 micrograms ml-1. The method is found to be sufficiently selective for the reliable determination of related compounds, FI-7001, FI-7009 and FI-7011, as indicated by same-day and between-day relative standard deviations (RSD) for replicate assays of 1.72% (n = 9) and 2.17% (n = 24), respectively. The application of this method to a cream formulation of sertaconazole nitrate is found to give a mean percentage recovery of 99.4% with RSD of 1.14% (n = 9); none of the cream vehicle peaks are found to interfere with the determination of sertaconazole nitrate.