STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE DETERMINATION OF GEFITINIB IN BULK FORM AND MARKETED PHARMACEUTICAL DOSAGE FORM BY USING RP-HPLC

A simple, reproducible, and efficient reverse phase high performance liquid chromatographic method was developed for determination of Gefitinib in pure form and marketed pharmaceutical dosage forms. A column having Kromasil C₁₈, 250 mm x 4.6 mm i.d.5µm particle size in isocratic mode with mobile phase containing Methanol: Acetonitrile (65:35 v/v) was used. The flow rate was 1.0 ml/min, and the effluent was monitored at 245 nm. The retention time (min) and linearity range (ppm) for Gefitinib were (2.800 min) and (6-14µg/ml) respectively. The method has been validated for linearity, accuracy, and precision, robustness, and limit of detection, and limit of quantitation. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.507μg/ml and 1.539μg/ml for Gefitinib respectively. The developed method was found to be accurate, precise and selective for determination of Gefitinib in bulk and marketed pharmaceutical dosage form.

Key Words: Gefitinib, RP-HPLC, Accuracy, Precision, Robustness, ICH Guidelines.