Development and validation of an HPLC method for voriconazole active substance in bulk and its pharmaceutical formulation

Abstract

The aim of the present study was to develop and validate a High-Performance Liquid Chromatography (HPLC) method for the determination of voriconazole in drug substances and in situ gel. A mixture of acetonitrile and ultrapure water (50: 50) (v/v) was used as mobile phase. The column was a C18 column (150x4.6mm with 5 mu m particles). The eluent was monitored with UV detection at 256 nm and flow rate was set to 1 mL/min. The method was validated partially with respect to system suitability, linearity, limits of detection (LOD) and quantitation (LOQ), precision, accuracy, specificity, selectivity and stability. Obtained results showed that the analytical method had good linearity, accuracy, precision, selectivity and stability. Analytical method development results indicated that the LOD was 0.022 mu g/mL; LOQ was 0.065 mu g/mL and assay exhibited a linear range of 1-30 mu g/mL.