Abstract

A NOVEL ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF ITRACANAZOLE BY UV SPECTROSCOPIC METHOD

Malkapuram Madhavi* and Santhosh Illendula

Abstract

A novel, accurate, precise, and economical UV spectrophotometric method was successfully developed and validated for the estimation of Itraconazole in bulk and pharmaceutical dosage forms. Itraconazole, a synthetic triazole antifungal agent, exhibits poor aqueous solubility, making its analysis challenging using simple techniques. In this study, methanol: water in a ratio of 70:30 was selected as the solvent system based on the drug’s solubility profile. The standard solution was scanned in the UV range (200–400 nm), and the maximum absorbance (λmax) was observed at 262 nm. The method was validated in accordance with ICH Q2 (R1) guidelines. It demonstrated excellent linearity in the concentration range of 5–25 μg/mL, with a correlation coefficient (R²) of 0.999, indicating a strong linear relationship between concentration and absorbance. Accuracy was confirmed through recovery studies, with results ranging from 98% to 102%, proving minimal interference from excipients. Precision studies showed %RSD values below 2%, confirming good repeatability and reproducibility. The Limit of Detection (LOD) and Limit of Quantification (LOQ) were calculated to be 1.25 μg/mL and 3.80 μg/mL, respectively. Robustness testing, performed by making minor variations in wavelength and solvent composition, showed no significant effect on results, confirming the method’s reliability. This validated UV spectrophotometric method is simple, cost-effective, and suitable for routine quality control and academic research applications.

Keywords: Itraconazole, UV spectrophotometry, analytical method development, λmax 262 nm, ICH Q2(R1) guidelines, precision, accuracy, bulk drug estimation, pharmaceutical analysis.