Development and Validation of an RP-HPLC Method for the Quantitative Estimation of Itraconazole in Bulk and Capsule Dosage Forms

Abstract

This study presents the development and validation of a simple, precise, accurate, and robust Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method for the quantitative analysis of Itraconazole in bulk and capsule forms. Chromatographic separation was carried out using a C18 column with an optimized mobile phase, flow rate, and detection wavelength to ensure effective resolution and symmetrical peak shapes. The method was validated under ICH guidelines, assessing parameters such as linearity, precision, accuracy, specificity, robustness, limit of detection (LOD), and limit of quantification (LOQ). The developed method demonstrated excellent linearity (R² > 0.999), accuracy with recoveries between 98–102%, and precision with RSD below 2%. No interference was observed from excipients or degradation products, confirming the method’s specificity. Robustness testing confirmed the system’s reliability under minor changes in conditions. Therefore, this RP-HPLC method is suitable for routine quality control of Itraconazole in pharmaceutical formulations.