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 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, 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 µg/ml; lOQ was 0.065 µg/ml and assay exhibited a linear range of 1-30 µg/ml.

Formulation and Detailed Characterization of Voriconazole Loaded in Situ Gels for Ocular Application

“…The mobile phase was a mixture of acetonitrile: ultrapure water (50:50). The retention time of VCZ was 4.098 min [7]. The method was validated for linearity, limit of detection (LOD) and limit of quantitation (LOQ), precision, accuracy and specificity, selectivity and stability.…”

“…The extent of scarring may be limited if the infection is identified early and treated adequately [4,5] A second-generation antifungal agent, voriconazole (VCZ), has exceptional properties such as broad-spectrum activity against resistant fungal species and acceptable tolerability. Besides, studies have demonstrated excellent efficacy of VCZ against ocular mucosa following topical administration [6,7].…”

Assessment of greenness for the determination of voriconazole in reported analytical methods

“… 72 Although the linearity selected in the reported HPLC methods did not broadly vary from the corresponding procedures, the chosen narrow range among the methods was 1 to 30. 73 Detectors like UV and photo diode array (PDA) were considered as another important factor for more accurate analysis of drugs with the reported methods of RP-HPLC. Among the two detectors PDA was selected by most of the methods due to their advantages like fast and more sensitive detection at multiple wavelengths.…”

A Review on Analysis of Voriconazole.

“…This validated method is successfully applied to determine the concentration of voriconazole in plasma after intravenous administration of 36 mg/kg voriconazole to rats and 10 mg/kg voriconazole to beagle dogs, respectively. Üstündağ Okur et al [8] 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.…”