Quantification of Impurity-E in Voriconazole Powder for Solution for Infusion (200 mg/vial) by using High Performance Liquid Chromatography

Abstract

A novel stability indicating liquid chromatographic method was developed and validated for the quantification of impurity-E((±)-βCamphorsulfonic acid, (±)-Camphor-10-sulfonic acid)in Voriconazole powder for solution for infusion formulation. The separation was achieved on Novapak (150 x 3.9 mm, 4 μm) column using a movable segment consisting of pH 5.0 acetate buffer and acetonitrile gradient elution mode, at a flow rate of 1.0 ml/min. Column oven maintained at 35°C, inoculation quantity 50 µl, sample cooler temperature 5 °C and detection wavelength 286 nm. Chromatographic resolution between impurity-E and Voriconazole was found to be 22.1. Technique was extensively validated for the quantification of impurity-E in Voriconazole powder for solution for infusion formulation and established to be vigorous. Method was established extremely specific as all other related impurities were separated from the impurity-E. The Limit of quantitation (LOQ) and limit of detection (LOD) for impurity-E were 6.0μg/ml and 2.0 μg/ml respectively.