title: How to solve the problem of co-elution between two compounds in liquid chromatography through the first UV derivative spectrum. A trial on alternative plasticizers to di(2-ethylhexyl) phthalate.
abstract: To meet new regulations, alternative plasticizers to di(2-ethylhexyl) phthalate (DEHP) are now commonly used in the manufacturing of medical devices. These are: acetyl tri-n-butyl citrate (ATBC), bis (2-ethylhexyl)adipate (DEHA), dioctyl terephtalate (DEHT), di-isononylphtalate (DINP), diisononylcyclohexane-1.2-dicarboxylate (DINCH) and trioctyltrimellilate (TOTM). An HPLC-UV analysis was previously developed to characterize four of them. However, two compounds were systematically co-eluated: DEHP with DEHA and DEHT with DINP. The first derivative of UV spectra and photodiode array detection allow the quantification of DEHA and DINP. Moreover, for each plasticizer, maximum wavelength absorbance was chosen to be as specific as possible. Quantification ranged from 0.3 to 750µg/mL according to the plasticizer. The assays were validated by analysis of variance. Our method was validated by determining the following parameters: specificity, linearity, limits of detection and quantification. The relative biases were inferior to 5% for ATBC, DEHP, DEHA and DINCH and inferior to 10% for DEHT, DINP and TOTM. Plasticizers were extracted with tetrahydrofuran and methanol. The developed method was then used to determine the composition of plasticizers in several medical devices used in clinical service. The major plasticizers were quantified from 19% to 40% w/w, traces of DEHT were found in six medical devices and DEHP in five.
authors.affiliation: Univ. Lille, EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000 Lille, France; CHU Lille, Institut de Pharmacie, F-59000 Lille, France.
authors.forename: Morgane
authors.initials: M
authors.lastname: Masse
authors.affiliation: Univ. Lille, EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000 Lille, France; CHU Lille, Institut de Pharmacie, F-59000 Lille, France. Electronic address: stephanie.genay@univ-lille2.fr.
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Genay
authors.affiliation: Univ. Lille, EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000 Lille, France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Feutry
authors.affiliation: Univ. Lille, EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000 Lille, France; CHU Lille, Institut de Pharmacie, F-59000 Lille, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Simon
authors.affiliation: Univ. Lille, EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000 Lille, France.
authors.forename: Christine
authors.initials: C
authors.lastname: Barthélémy
authors.affiliation: Clermont Université, Université d'Auvergne, EA 4676, C-BIOSENSS, BP 10448, 63000 Clermont-Ferrand, France; CHU Clermont-Ferrand, Pôle Pharmacie, rue Montalembert, 63003 Clermont-Ferrand, France.
authors.forename: Valérie
authors.initials: V
authors.lastname: Sautou
authors.affiliation: Univ. Lille, EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000 Lille, France; CHU Lille, Institut de Pharmacie, F-59000 Lille, France.
authors.forename: Bertrand
authors.initials: B
authors.lastname: Décaudin
authors.affiliation: Univ. Lille, EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000 Lille, France; CHU Lille, Institut de Pharmacie, F-59000 Lille, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Odou
authors.affiliation: Univ. Lille, EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000 Lille, France; CHU Lille, Institut de Pharmacie, F-59000 Lille, France; Clermont Université, Université d'Auvergne, EA 4676, C-BIOSENSS, BP 10448, 63000 Clermont-Ferrand, France; CHU Clermont-Ferrand, Pôle Pharmacie, rue Montalembert, 63003 Clermont-Ferrand, France.
authors.lastname: For The Armed Study Group
keywords: Chromatography; Diethylhexyl phthalate/analysis; High pressure liquid/methods; Materials testing; Plasticizers/analysis; Polyvinyl chloride/analysis