ABSTRACT:
A simple, precise, rapid and accurate reverse phase HPLC method developed for the estimation of Gefitinib in tablet dosage form. An Hypersil BDS RP C18, 250x4.6 mm, 5 µm partical size, with mobile phase consisting of 0.02 M Dipotassium Hydrogen ortho phosphate and Methanol in the ratio of 10:90 v/v was used. The flow rate was 1.0 ml/min and the effluents were monitored at 246 nm. The retention time was 3.7 min. The detector response was linear in the concentration of 25-300µg/ml. The respective linear regression equation being Y= 94342.26x+77672.7. The limit of detection and limit of quantification was 0.125µg/ml and 0.15µg/ml respectively. The percentage assay of Gefitinib was 99.5 %. The method was validated by determining its accuracy, precision and system suitability. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Gefitinib in bulk drug and in its pharmaceutical dosage form.