Vol. 7, Issue 2, Part B (2025)

A simple, accurate, novel, safe, and precise method was developed for the quantification of Itraconazole (ITZ), a poorly water-soluble drug, in bulk and tablet dosage forms using various hydrotropic reagents. Among the hydrotropic agents tested, a combination of PABA (para-amino benzoic acid) and citric acid in a 1:1 ratio showed the maximum absorbance. Sodium acetate, however, did not exhibit any absorbance above 240 nm, which indicated no interference in the estimation of the drug. ITZ followed Beer's law within the concentration range of 15-75 µg/ml (r² = 0.999). The standard deviation, coefficient of variation, and standard error for ITZ were found to be satisfactorily low. The developed method was validated according to ICH guidelines, and the values of accuracy, precision, and other statistical analyses were found to be in good accordance with the prescribed values. Therefore, this method can be used for routine monitoring of ITZ in the pharmaceutical industry for the assay of bulk drug and tablets.