Separation and estimation of process-related impurities of gefitinib by reverse-phase high-performance liquid chromatography.

A simple and rapid reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous separation and estimation of gefitinib (an anti-cancer drug) and its process-related impurities. Five process-related impurities of gefitinib were separated on an Inertsil ODS-3V column (250 × 4.6 mm i.d.; particle size 5 μm) using 130 mM ammonium acetate and acetonitrile (63:37, v/v) as mobile phase (pH 5.0) with a photodiode array (PDA) detector. The correlation coefficients for gefitinib and its process-related impurities were in the range of 0.9991-0.9994 with limit of detection and limit of quantification in the range of 0.012-0.033 and 0.04-0.10 µg/mL, respectively. The recovery values were in the range of 98.26-99.90% for gefitinib and 95.99-100.55% for process-related impurities, while precision values were less than 3%. The method was found to be specific, precise and reliable for the determination of gefitinib and its impurities in gefitinib bulk drug.