METHOD DEVELOPMENT AND VALIDATION OF AFATINIB IN BULK AND PHARMACEUTICAL DOSAGE FORM BY UVSPECTROSCOPIC METHOD

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<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 Afatinib in bulk and tablet dosage form. Keywords: Afatinib, UV Visible Spectrophotometry, Method development, Validation, ICH guidelines, Sodium citrate , Accuracy, Precision.