title: Separation and estimation of process-related impurities of gefitinib by reverse-phase high-performance liquid chromatography.
abstract: 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.
authors.affiliation: Vittal Mallya Scientific Research Foundation (VMSRF), #94/3 & 94/5, 23rd Cross, 29th Main, BTM II Stage, Bengaluru 560076, India.
authors.forename: Karunakara A
authors.initials: KA
authors.lastname: Chandrashekara
authors.affiliation: Vittal Mallya Scientific Research Foundation (VMSRF), #94/3 & 94/5, 23rd Cross, 29th Main, BTM II Stage, Bengaluru 560076, India.
authors.forename: Aparna
authors.initials: A
authors.lastname: Udupi
authors.affiliation: Vittal Mallya Scientific Research Foundation (VMSRF), #94/3 & 94/5, 23rd Cross, 29th Main, BTM II Stage, Bengaluru 560076, India.
authors.forename: Chandrasekara G
authors.initials: CG
authors.lastname: Reddy
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D056148:Chromatography, Reverse-Phase / Q000379:methods*; D004340:Drug Contamination; D000077156:Gefitinib; D011799:Quinazolines / Q000737:chemistry*; D015203:Reproducibility of Results
chemical_list: D011799:Quinazolines; D000077156:Gefitinib