IDENTIFICATION AND QUANTIFICATION OF RELATED COMPOUNDS C&D IN VORICONAZOLE BY HPLC

Abstract

An isocratic reversed-phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for the identification & quantification of related substances C & D. The successful separation of voriconazole from its synthetic impurities and degradation products formed under stress conditions was achieved using 3.9mm x 15cm, 4µm Packing L1 or equivalent column maintained at 25°C with a mobile phase of a Acetonitrile: Methanol (55:15:30). The mobile phase flow rate was 1.0 mL/min, and the detection wavelength was 256 nm. The developed HPLC method was validated with respect to linearity, accuracy, precision, specificity, and robustness. The developed HPLC method to determine the related substances and assay determination of voriconazole can be used to evaluate the quality of regular production samples. It can be also used to test the stability samples of voriconazole.