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TITLE:

METHOD DEVELOPMENT AND VALIDATION OF AXITINIB IN BULK AND PHARMACEUTICAL DOSAGE FORM BY UV-SPECTROSCOPIC METHOD

AUTHORS:

SanthoshIllendula, A.NavyaSree, CH.Ganesh, K.Sneha, M.Sravya,B.Sayujya, P.Sandhya, V.Shirisha,K.N.V. Rao, K. RajeswarDutt.

ABSTRACT:

A new simple, accurate, rapid, precise, reproducible and cost effective spectrophotometric method for the quantitative estimation of Axitinib in bulk and pharmaceutical dosage form. The developed visible spectrophotometric method for the quantitative estimation of Axitinib is based on measurement of absorption at maximum wavelength 253 nm using DMF with Water as a solvent. The stock solution of Axitinib was prepared, and subsequent suitable dilution was prepared in distilled water to obtained standard curve. The standard solution of Axitinib shows absorption maxima at 253 nm. The drug obeyed beer lambert’s law in the concentration range of 5 - 25μg/ml with regression 0.999 at 253 nm. The overall % recovery was found to be 99.6% which reflects that the method was free from the interference of the impurities and other excipients used in the bulk and marketed dosage form. The low value of % RSD was indicative of accuracy and reproducibility of the method. The % RSD for inter-day and intra-day precision was found to be 0.0326 and 0.0415 respectively which is<2% 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 Axitinib in bulk and tablet dosage form. Keywords: Axitinib, UV Visible Spectrophotometry, Method development, Validation, ICH guidelines, DMF, Accuracy, Precision.

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Creative Commons License This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.