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 Shankar, G Kiranmayi
2012 Int. J. Chem. Sci   unpublished
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,
more » ... nge, precision, robustness, ruggedness, stability, specificity, LOD, LOQ and system suitability parameters were validated for the developed method.
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