Development and validation of novel stability indicating RP-HPLC method for the determination of assay of voriconazole in pharmaceutical products

Abstract

For the determination of the assay of voriconazole in bulk and in pharmaceutical dosage forms, a novel stability indicating RP-HPLC method was designed and validated, exhibiting a very low run time. The stability-indicating nature of the approach is supported by the fact that it is unique, quick, precise, accurate, and capable of isolating the voriconazole peak from any contaminating or degrading components. Isocratic elution on a 100 mm x 4.6 mm, 3μm agilent C18 column at 45°C and a UV detection wavelength of 256 nm constitutes the analytical procedure at at a flow rate of 1.0 mL/min. After injecting 20µL of voriconazole sample, the elution peak occurred at 3.5 minutes, and the entire run time was 15 minutes. Between 98% and 102% was a reasonable range for the percentage of recovery. It was determined that the method's RSD for precision and accuracy was less than 2%. The method has been verified for routine analysis of voriconazole in bulk materials and its formulations according to the standards established by the International Conference on Harmonization (ICH).