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Development and Validation of a Sensitive Reversed-Phase HPLC Method for the Determination of Gefitinib in Bulk and in its Pharmaceutical Formulation

D. Peer Basha, K. Ravi Shankar and G. V. N. Kiranmayi

A rapid and sensitive RP-HPLC method with UV detection at 205 nm for routine analysis of Gefitinib in bulk and pharmaceutical formulations was developed. Chromatography was performed with mobile phase containing a mixture of acetonitrile and 0.5% M ammonium dihydrogen phosphate buffer in the ratio of 30 : 70, v/v with flow rate 1.0 mL/min. The calibration curve of Gefitinib was found to be linear over the range of 0.05 to 0.15 mg/mL with correlation coefficient of 0.99. Sensitivity, accuracy, range, precision, robustness, ruggedness, stability, specificity, LOD, LOQ and system suitability parameters were validated for the developed method.