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Development and validation of spectroscopic methods for the estimation of Gefitinib in bulk and in tablet formulation

Vivekkumar K.Redasani, Priyanka S.Patel, Sanjay J.Surana

Three simple, precise, specific and cost effective spectrophotometric methods have been developed for the estimation of Gefitinib in bulk and its tablet formulation. Gefitinib was estimated at 250 nm in UV-spectroscopy (MethodA), 261 nm in first order derivative spectroscopy (Method B) and scanned at 254.78 - 260.390 nm in area under curve (Method C). The drug follows Beer-LambertÂ’s law in the concentration range of 2 -12 ìg/ml in all three methods. All the methods were validated by following the analytical performance parameters suggested by International Conference on Harmonization (ICH) guidelines.All validation parameterswere within the acceptable range. The developed methods were successfully applied to estimate the amount of Gefitinib in bulk and in tablet formulation.