A NOVEL ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ITRACONAZOLEBYUSING UV SPECTROSCOPIC METHOD

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A. NAVYA SRI, LEJANNA KISHORE, M.BHUVANESHWARI, B.HARIKRISHNA, Dr. K. N. VENKATESWARA RAO

ABSTRACT: A new simple, accurate, rapid, precise and reproducible spectrophotometric method for the development and validation of Itraconazole in tablet dosage form. The developed visible spectrophotometric method for the validation of Itraconazole is based on measurement of absorption at maximum wavelength 261 nm using with Acetonitrile (100%) as a solvent. The stock solution of Itraconazole was prepared, and subsequent suitable dilution was prepared to obtain standard curve. The stock solution of Itraconazole shows absorption maxima at 261 nm. The drug obeyed beer lambert’s law in the concentration range of 5-25 µg/ml with regression 1 at 261 nm. The overall % recovery was found to be 98.45% which reflects that the method was passed in tablet dosage form. The low value of % RSD was indicative of accuracy and reproducibility of the method. The LOD and LOQ were found to be 0.39865 µg/ml and 0.905 µg/ml which is hence proved that method is precise. The results of analysis have been validated as per International Conference on Harmonization (ICH) guidelines. The developed method can be adopted in routine analysis of Itraconazole in dosage form.

Itraconazole, UV Visible Spectrophotometry, Method development, Validation, ICH guidelines, Acetonitrile, Accuracy, Precision.