Novel Stability indicating Rp-HPLC Method for the Determination of Assay of Voriconazole in Pharmaceutical Products

A novel stability indicating RP-HPLC method having a very short run time was developed and validated for determination of assay of Voriconazole in bulk solution, lyophilized injectable dosage form and in physiological compatible solutions. The method is novel, rapid, precise, accurate and capable of separating known impurities and degradants from Voriconazole peak proving the stability-indicating nature of the method. The analytical method consists of isocratic elution at a flow rate of 0.8 mL/min on a Devolosil C18 column (100 x 4.6 mm, 3μm) at temperature of 45°C and UV detection wavelength of 254 nm. 10μL of the voriconazole sample was injected and peak was eluted at about 2.5 min. with total run time of 10 minutes. The % recovery was well within the range between 98% and 102%. The RSD for precision and accuracy of the method was found to be less than 2%. The method was validated as per the International Conference on Harmonization (ICH) guidelines and can be successfully applied for routine analysis of Voriconazole in bulk samples and its formulations.