Chiral Analysis of Sertaconazole by HPLC Method on Polysaccharide Derivatives

Abstract

Sertaconazole is a pharmaceutical product in the form of a cream, gel, powder, and solution for dermatological use and vaginal cream, tablets, and ovules for gynecological use. The active ingredient is 2% sertaconazole nitrate. Sertaconazole nitrate is an azole antifungal agent, with notable antifungal activity. The active principal structure of sertaconazole has an asymmetric carbon, which makes this molecule chiral and it is in the form of an enantiomeric mixture. Currently, the control of drugs is based on qualitative and quantitative analysis by the use of effective analytical methods for chiral active ingredients. The enantiomeric separation of an antifungal compound, Sertaconazole, using HPLC is described in this work. The columns employed were based on polysaccharide derivatives (Chiralpak IB, Chiralcel OD-H), and the results show that the separations obtained are better, in terms of high resolution and short analysis time. Chiral separation of Sertaconazole was explained by hydrogen bondings and π-π interactions, between the CSP and this antifungal agent.