Development and Validation of Itraconazole capsule by using HPLC

Systemic and superficial fungal infections are commonly treated with itraconazole, a broadspectrum triazol antifungal medication. However, its oral bioavailability becomes a limiting issue because to its limited water solubility. In this work, a powder-based approach was used to formulate a solid dosage form, the itraconazole capsule, and High-Performance Liquid Chromatography (HPLC) was used to validate the quantification method. Preformulation research, excipient selection, capsule filling, and medication content optimization were all steps in the formulation process. Using a C18 column and a mobile phase consisting of acetonitrile and phosphate buffer, an appropriate reversed-phase HPLC technique was created. The accuracy, precision, linearity, specificity, and robustness of the technique were all verified in accordance with ICH Q2 (R1) requirements. Consistent in vitro release, appropriate disintegration time, and adequate drug content homogeneity were all demonstrated by the proposed formulation. Excellent sensitivity and specificity were shown by the validated HPLC technique for estimating the amount of itraconazole in capsule form. According to the study's findings, the developed capsule and analytical technique may be scaled up for commercial manufacturing and are appropriate for regular quality monitoring