Development and Validation of an Hplc Method for Voriconazole Active Substance in Bulk and its Pharmaceutical Formulation

Neslihan Üstündağ Okur, Emre Şefik Çağlar, Vildan YOZGATLI
2016 MARMARA PHARMACEUTCAL JOURNAL  
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 5µm 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,
more » ... y, 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 µg/ml; lOQ was 0.065 µg/ml and assay exhibited a linear range of 1-30 µg/ml.
doi:10.12991/mpj.20162076793 fatcat:ocfnn7btovahzaanxf2iesyirm