VALIDATED CHROMATOGRAPHIC METHOD FOR DETERMINATION OF VORICONAZOLE IN TABLETS THROUGH RP- HPLC

K. G. Suryawanshi, N. A. Porwar, K. A. Patil, K. K. Khadke, Y. R. Patil,  Dr. K. R. Patil*, S. N. Patil, Dr. S. D. Barhate

Voriconazole is a broad-spectrum triazole antifungal agent widely used in the treatment of invasive fungal infections. The present study focuses on the development and validation of a simple, accurate, and cost-effective analytical method for the quantitative estimation of voriconazole using RP-HPLC and UV spectrophotometry. Chromatographic separation was achieved using a C18 column with a mobile phase consisting of methanol and 0.1% orthophosphoric acid in water (80:20 v/v), at a flow rate of 1.0 mL/min and detection wavelength of 256 nm.The method was validated according to ICH guidelines for parameters including linearity, accuracy, precision, robustness, limit of detection (LOD), and limit of quantification (LOQ). The method exhibited excellent linearity in the concentration range of 5–25 µg/mL with a correlation coefficient (R²) of 0.999. Recovery studies confirmed the accuracy of the method with values between 98–101%, while precision studies showed %RSD less than 2%, indicating high reproducibility. The LOD and LOQ were found to be 0.0917 µg/mL and 0.2779 µg/mL, respectively.The developed method was successfully applied to the analysis of pharmaceutical formulations, demonstrating its suitability for routine quality control. Overall, the method is simple, sensitive, precise, and economical, making it ideal for the estimation of voriconazole in bulk and dosage forms.