Journal of Chemical and Pharmaceutical Research (ISSN : 0975-7384)

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Original Articles: 2015 Vol: 7 Issue: 12

Development and validation of UV spectrophotometric method for the determination of Nilotinib hydrochloride (An orphan drug)

Abstract

A simple, accurate, precise and sensitive UV spectrophotometric method was developed for the determination of Nilotinib hydrochloride in bulk and pharmaceutical dosage form. The solvent used is Methanol:Water (1:1) and the wavelength corresponding to the maximum absorbance of the drug was found at 263 nm. Beers law was observed in the concentration range of 7- 12μg/mL with correlation coefficent R² = 0.9984. The linear regression equation obtained by least square regression method were y = 0.1094x - 0.3008, where y is the absorbance and x is the concentration of the pure drug solution. The method was validated for several parameters like accuracy, precision as per ICH guidelines. The values of the relative standard deviation and % recovery were found to be satisfactory, indicating that the proposed method is precise and accurate and hence can be used for the routine analysis of Nilotinib hydrochloride in bulk and pharmaceutical formulation