title: A HPLC validated assay of paclitaxel's related impurities in pharmaceutical forms containing Cremophor EL.
abstract: A HPLC method has been developed for the determination of the paclitaxel's related impurities in pharmaceutical forms. This method ensures the rapid determination of related impurities in the presence of polyoxyl castor oil--the main constituent of paclitaxel's clinical formulation vehicle. The method is simple and does not require any preliminary treatment of the sample. The method was fully validated.
authors.affiliation: Sindan Pharmaceutical Co., 11 Ion Mihalache Blvd., 78168 Bucharest, Romania.
authors.forename: Dana
authors.initials: D
authors.lastname: Ciutaru
authors.forename: Irinel
authors.initials: I
authors.lastname: Badea
authors.forename: Lelia
authors.initials: L
authors.lastname: Lazara
authors.forename: Daniela
authors.initials: D
authors.lastname: Nicolescu
authors.forename: Aurel
authors.initials: A
authors.lastname: Tudose
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods; D004340:Drug Contamination; D005990:Glycerol / Q000031:analogs & derivatives* / Q000032:analysis*; D017239:Paclitaxel / Q000032:analysis*; D004364:Pharmaceutical Preparations / Q000032:analysis
chemical_list: D004364:Pharmaceutical Preparations; C000515:cremophor EL; D017239:Paclitaxel; D005990:Glycerol