DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR THE ESTIMATION OF ITRACONAZOLE IN TABLET BY RP-HPLC

Itraconazole (ITRA) is a broad-spectrum antifungal agent widely used for the treatment of systemic and superficial fungal infections. Due to its poor water solubility and variable bioavailability, a precise and validated analytical method is essential for its accurate quantification in pharmaceutical dosage forms. The present study aimed to develop and validate a simple, accurate, and robust reverse-phase high-performance liquid chromatography (RP-HPLC) method for the estimation of Itraconazole in tablet formulations. The method was developed using an Inertsil C18 column (250 mm × 4.6 mm, 5 μm) with a mobile phase consisting of Acetonitrile: Potassium dihydrogen phosphate buffer (65:35 v/v), pH adjusted to 3.5. The flow rate was maintained at 1 mL/min and detection was carried out at 258 nm. Physicochemical characterization including melting point (167°C), FTIR, and UV analysis (λmax 258 nm) confirmed the identity and purity of the drug. The retention time of Itraconazole was found to be sharp and consistent with good peak symmetry. The method was validated as per ICH Q2(R1) guidelines and was found to be linear (R² = 0.9999) over the concentration range of 10–100 µg/mL. Accuracy, precision, specificity, ruggedness, robustness, and system suitability parameters were all within acceptable limits. The method was successfully applied to the analysis of laboratory mixtures and marketed formulations. This study concludes that the proposed RP-HPLC method is highly suitable for routine quality control analysis of Itraconazole in tablet dosage forms. KEYWORDS: Itraconazole, RP-HPLC, Method Development, Method Validation, Tablet Formulation, UV Spectroscopy, FTIR, ICH Guidelines, Mobile Phase Optimization, Pharmaceutical Analysis etc.