title: Phthalates determination in pharmaceutical formulae used in parenteral nutrition by LC-ES-MS: importance in public health.
abstract: A method for determining a group of phthalate esters in pharmaceutical formulae used in parenteral nutrition samples (with and without vitamins) has been developed. The phthalic acid esters (PAEs) studied were dimethyl phthalate, diethyl phthalate, butyl benzyl phthalate, dibutyl phthalate, di-(2-ethylhexyl) phthalate, and dioctyl phthalate. This group of phthalates was determined by high performance liquid chromatography (HPLC)-electrospray ionization-mass spectrometry, working in positive ion mode. The phthalates analyzed were extracted from the sample using hexane and sodium hydroxide. The hexane was then evaporated, and the compounds were redissolved in acetonitrile. The compounds were separated by HPLC working in gradient mode with acetonitrile-ultrapure water starting from 5% to 75% acetonitrile in 5 min, followed by isocratic elution for 27 min. Standard calibration curves were linear for all the analytes over the concentration range 10-250 microg L(-1). The method was precise (with RSD from 3.3% to 12.9%) and sensitive. The proposed analytical method has been applied to the analysis of these compounds in different pharmaceutical formulae (with different compositions) for parenteral nutrition samples in order to check the presence of phthalates and determine their concentration.
authors.affiliation: Department of Analytical Chemistry, Nutrition and Bromatology, University of Santiago de Compostela, Santiago de Compostela, 15782, Spain.
authors.forename: Cristina
authors.initials: C
authors.lastname: Pérez-Feás
authors.forename: María Carmen
authors.initials: MC
authors.lastname: Barciela-Alonso
authors.forename: Antía
authors.initials: A
authors.lastname: Sedes-Díaz
authors.forename: Pilar
authors.initials: P
authors.lastname: Bermejo-Barrera
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004304:Dosage Forms; D010288:Parenteral Nutrition; D010795:Phthalic Acids / Q000032:analysis*; D012680:Sensitivity and Specificity; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods*
chemical_list: D004304:Dosage Forms; D010795:Phthalic Acids