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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.

A simple and rapid reverse-phase high-performance liquid chromatographic (RP-HPLC) method for the estimation of intermediates formed during the synthesis of anti-cancer drug erlotinib via quinazoline-thione route has been developed. The intermediates formed during the 7-step synthesis of erlotinib have been separated on a Inerstsil ODS-3 V (C18) column with isocratic elution using 1% ammonium acetate and acetonitrile (55:45 v=v) as mobile phase, with flow rate of 1 mL=min and detected at 254 nm using Photo Diode Array (PDA). The developed method was validated for accuracy, precision, linearity, limit of detection (LOD), limit of quantification (LOQ) and ruggedness. The correlation coefficients for calibration curves of intermediates were in the range of 0.995-0.999. The proposed reverse-phase HPLC method was successfully applied for the estimation of intermediates=impurities present in erlotinib bulk drug; the recoveries of intermediates were in the range of 96.83-100.96% and precision values were less than 3%. The method was found to be specific, precise, and reliable for the determination of intermediates and synthetic impurities in erlotinib bulk drug.

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