Abstract :
A new simple, accurate, rapid, precise, reproducible and cost effective spectrophotometric method for the
quantitative estimation of Afatinib in bulk and pharmaceutical dosage form. The developed visible
spectrophotometric method for the quantitative estimation of Afatinib is based on measurement of absorption at
maximum wavelength 246 nm using Sodiumcitrate with Water as a solvent. The stock solution of Afatinib was
prepared, and subsequent suitable dilution was prepared in distilled water to obtained standard curve. The standard
solution of Afatinib shows absorption maxima at 246 nm. The drug obeyed beer lambert’s law in the concentration
range of 5 - 25 μg/ml with regression 0.999 at 246 nm. The overall % recovery was found to be 99.03% 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 0.298 and 0.2941respectively which is
Keyword :
Afatinib, UV Visible Spectrophotometry, Method development, Validation, ICH guidelines, Sodium citrate , Accuracy, Precision.