Abstract

METHOD DEVELOPMENT AND VALIDATION OF ITRACONAZOLE BY UV-SPECTROPHOTOMETER

M. Koteswara Rao*, K.V. Ramanjaneyulu, SK. Reehana, D. Narasimha Rao, D.L.Sujana,, J.N.Suresh Kumar

Abstract

is a synthetic triazole antifungal agent. Itraconazole was formulated into several pharmaceutical forms through various routes of administration. Itraconazole capsules are used to treat fungal infections in the lungs that can spread throughout the body. For quality control and stability testing of Itraconazole in pharmaceutical formulations, limited methods have been published, because the drug is not yet official in any pharmacopoeia. The present work is have made an attempt to develop a more precise, simple and economical spectrophotometric method with greater precision, accuracy and sensitivity for the analysis of Itraconazole in bulk and capsule dosage forms. UV spectroscopic determination was carried out at an absorption maximum of 267 nm using Chloroform as solvent. In the UV spectroscopic method linearity over the concentration range of Itraconazole was found to be 1-10 μg/ml with a correlation coefficient 0.999. Results of the analyses were validated statistically and by recovery studies. The method was validated by the parameters like linearity, precision, accuracy, limit of detection and limit of quantification were studied according to International Conference on Harmonization guidelines.

Keywords: Itraconazole, pharmacopoeia, UV spectroscopic method, Quality control.