title: Quantification of five plasticizers used in PVC tubing through high performance liquid chromatographic-UV detection.
abstract: Searching for alternatives to di-(2-ethylhexyl)-phthalate, a plasticizer that has been widely used in the manufacturing of PVC medical devices, has become a major challenge since a European regulation underlined some clinical risks. The aim of this study is to develop an HPLC-UV method to quantify the currently used alternative plasticizers to DEHP. Five plasticizers, acetyl tributyl citrate, di-(2-ethylhexyl)-phthalate, di-(ethylhexyl)-terephthalate, di-isononyl-1,2-cyclohexane-dicarboxylate, and trioctyl trimellitate, were separated on a C8 stationary phase (2.6 μm, 100 mm × 4.6mm) under gradient elution in 13 min. They were detected at 221 nm leading to a quantification threshold from 0.3 to 750 μg/mL as a function of the plasticizer. Within-day and between-day precisions were inferior to 0.9% and 18%, respectively. The assays were validated according to the accuracy profile method. Plasticizers were extracted from PVC-tubing by dissolving PVC in THF then precipitating it in methanol with a yield of over 90% for each plasticizer. This assay could feasibly be used to quantify plasticizers in PVC medical devices.
authors.affiliation: Univ. Lille Nord de France, UDSL, EA 4481, France; Department of Biopharmacy, Galenic and Hospital Pharmacy, Faculty of Pharmacy, Lille, France.
authors.forename: Tsanta
authors.initials: T
authors.lastname: Radaniel
authors.affiliation: Univ. Lille Nord de France, UDSL, EA 4481, France; Department of Biopharmacy, Galenic and Hospital Pharmacy, Faculty of Pharmacy, Lille, France; Pharmacy Institute, University Hospital, Lille, France.
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Genay
authors.affiliation: Univ. Lille Nord de France, UDSL, EA 4481, France; Department of Biopharmacy, Galenic and Hospital Pharmacy, Faculty of Pharmacy, Lille, France; Pharmacy Institute, University Hospital, Lille, France. Electronic address: nicolas.simon@univ-lille2.fr.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Simon
authors.affiliation: Univ. Lille Nord de France, UDSL, EA 4481, France; Department of Biopharmacy, Galenic and Hospital Pharmacy, Faculty of Pharmacy, Lille, France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Feutry
authors.affiliation: Univ. Lille Nord de France, UDSL, EA 4481, France; Department of Biopharmacy, Galenic and Hospital Pharmacy, Faculty of Pharmacy, Lille, France.
authors.forename: Francesca
authors.initials: F
authors.lastname: Quagliozzi
authors.affiliation: Univ. Lille Nord de France, UDSL, EA 4481, France; Department of Biopharmacy, Galenic and Hospital Pharmacy, Faculty of Pharmacy, Lille, France.
authors.forename: Christine
authors.initials: C
authors.lastname: Barthélémy
authors.affiliation: Univ. Lille Nord de France, UDSL, EA 4481, France; Department of Analytical Chemistry, Faculty of Pharmacy, Lille, France.
authors.forename: Marie
authors.initials: M
authors.lastname: Lecoeur
authors.affiliation: Department of Pharmacy, University Hospital, Clermont-Ferrand, France; EA 4676 - C-Biosenss, Auvergne University, France.
authors.forename: Valérie
authors.initials: V
authors.lastname: Sautou
authors.affiliation: Univ. Lille Nord de France, UDSL, EA 4481, France; Department of Biopharmacy, Galenic and Hospital Pharmacy, Faculty of Pharmacy, Lille, France; Pharmacy Institute, University Hospital, Lille, France.
authors.forename: Bertrand
authors.initials: B
authors.lastname: Décaudin
authors.affiliation: Univ. Lille Nord de France, UDSL, EA 4481, France; Department of Biopharmacy, Galenic and Hospital Pharmacy, Faculty of Pharmacy, Lille, France; Pharmacy Institute, University Hospital, Lille, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Odou
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004864:Equipment and Supplies; D057230:Limit of Detection; D016014:Linear Models; D010968:Plasticizers / Q000032:analysis*; D011143:Polyvinyl Chloride / Q000737:chemistry*; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet / Q000379:methods*
chemical_list: D010968:Plasticizers; D011143:Polyvinyl Chloride
keywords: DEHP; HPLC; Medical devices; PVC (polyvinylchloride); Plasticizers