title: Separation and determination of process-related impurities of erlotinib using reverse-phase HPLC with a photo-diode array detector.
abstract: A simple and rapid reverse-phase high-performance liquid chromatographic (HPLC) method for the simultaneous separation and determination of erlotinib and its process-related impurities in bulk drugs has been developed. Five process-related impurities of erlotinib have been separated on an Inerstsil ODS-3V (C18) column and detected at 254 nm using a photo diode array (PDA). This HPLC method was successfully applied to the analysis of erlotinib bulk drug. The recoveries of erlotinib and process-related impurities were in the range of 92.86-106.23%, and found to be specific, precise and reliable for the determination of unreacted raw materials, intermediates in the reaction mixtures and bulk drugs.
authors.affiliation: Vittal Mallya Scientific Research Foundation, Bengaluru, India.
authors.forename: Chandrashekara
authors.initials: C
authors.lastname: Karunakara
authors.forename: Udupi
authors.initials: U
authors.lastname: Aparna
authors.forename: Venkateshappa
authors.initials: V
authors.lastname: Chandregowda
authors.forename: Chandrasekara G
authors.initials: CG
authors.lastname: Reddy
mesh_terms: D000970:Antineoplastic Agents / Q000032:analysis* / Q000302:isolation & purification*; D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation*; D056148:Chromatography, Reverse-Phase / Q000295:instrumentation*; D000069347:Erlotinib Hydrochloride; D008027:Light; D016014:Linear Models; D011799:Quinazolines / Q000032:analysis* / Q000302:isolation & purification*; D013997:Time Factors
chemical_list: D000970:Antineoplastic Agents; D011799:Quinazolines; D000069347:Erlotinib Hydrochloride