Abstract
Author(s): Asma A. Pathan*, Prasad R. Dhane, Pappu M. Tarange and Ahad J. Pathan
Itraconazole is a synthetic triazole antifungal agent. Itraconazole is formulated into several pharmaceutical forms available into market. Itraconazole capsules are used to treat fungal infection in the lungs that can spread throughout the body. Itraconazole is partially water soluble therefore methods available for assay of Itraconazole in pharmaceutical formulation use organic solvents thus available methods are not cost effective and difficult to routine use. In present work attempt has made to develop a more precise, simple and economical spectrophotometric method with combination of water and methanol as solvent with greater precision, accuracy and suitability for the quantitation of Itraconazole in capsule dosage form. UV spectroscopic determination was carried out at absorption maxima of 254 nm using Methanol: Water (40:60 % v/v) as solvent. In present UV spectroscopic method linearity over the concentration range of Itraconazole was found to be in between 50-150 μg/ml with a correlation coefficient 0.996. Results of the analyses where validated statistically and by recovery studies. The method was validated for the parameters like linearity, range, precision, accuracy, LOD and LOQ as per ICH Q2R1 guidelines.
