Development and validation of a stability-indicating micellar electrokinetic chromatography method to assay voriconazole tablets

Abstract

The aim of this study was to develop a micellar electrokinetic chromatography method (MEKC) in order to quantify voriconazole in tablets. The optimized conditions of the method were: background electrolyte composed of sodium tetraborate 10 mM and SDS 40 mM, pH 9.0; voltage of +27 kV; hydrodynamic injection of 5 s (50 mBar), and detection wavelength 207 nm. The separation was carried out in a fused-silica capillary (48.5 cm × 50 μm i.d., effective length 40 cm), maintained at 32 °C, using potassium diclofenac as an internal standard. The method was validated in accordance with the ICH requirements showing specificity, linearity (r = 0.9998, range of 30–100 μg mL⁻¹), precision (relative standard deviation lower than 2%), accuracy (mean recovery 100.44%), and robustness, which was evaluated by 2-Level 2^5-2 fractional factorial design. The proposed MEKC method was successfully applied for the quantitative analysis of voriconazole in tablets. Results were compared to those obtained by high performance liquid chromatography and ultraviolet spectrophotometric methods previously developed showing non-significant difference (p > 0.05).