A Simple Isocratic RP-HPLC Method for Quality Control of Oseltamivir Capsules

摘要

A simple isocratic reversed-phase high performance liquid chromatographic (RP-HPLC) method was developed for determination of oseltamivir active pharmaceutical ingredient (API) in bulk drug and pharmaceuticals. The separation was achieved on a Purospher STAR® RP – 18e column with a mobile phase consisting of methanol - 0.02 mol l–1 phosphate buffer, pH 5, 50:50 (V/V). Chromatographic results demonstrated the specificity of the method for determination of oseltamivir in presence of degradation products generated in studies of forced decomposition. The limit of detection (LOD) and limit of quantification (LOQ) for oseltamivir phosphate were 0.0162 μg ml–1 and 0.0491 μg ml–1, respectively. The advantages of this method include simple sample treatment, short elution time (less than 6 min) and short analysis time (less than 10 min). Furthermore, using methanol instead of acetonitrile in a mobile phase composition considerably reduces the laboratory expenses, still retaining adequate sensitivity for routine analysis as well as for evaluation of authenticity of Tamiflu® products.