title: Comparison of high-performance liquid chromatography and supercritical fluid chromatography using evaporative light scattering detection for the determination of plasticizers in medical devices.
abstract: Recently, interest in supercritical fluid chromatography (SFC) has increased due to its high throughput and the development of new system improving chromatographic performances. However, most papers dealt with fundamental studies and chiral applications and only few works described validation process of SFC method. Likewise, evaporative light scattering detection (ELSD) has been widely employed in liquid chromatography but only a few recent works presented its quantitative performances hyphenated with SFC apparatus. The present paper discusses about the quantitative performances of SFC-ELSD compared to HPLC-ELSD, for the determination of plasticizers (ATBC, DEHA, DEHT and TOTM) in PVC tubing used as medical devices. After the development of HPLC-ELSD, both methods were evaluated based on the total error approach using accuracy profile. The results show that HPLC-ELSD was more precise than SFC-ELSD but lower limits of quantitation were obtained by SFC. Hence, HPLC was validated in the ± 10% acceptance limits whereas SFC lacks of accuracy to quantify plasticizers. Finally, both methods were used to determine the composition of plasticized-PVC medical devices. Results demonstrated that SFC and HPLC both hyphenated with ELSD provided similar results.
authors.affiliation: Univ Lille Nord de France, UDSL, EA GRITA 7365, UFR Pharmacy, 59006 Lille, France. Electronic address: marie.lecoeur@univ-lille2.fr.
authors.forename: Marie
authors.initials: M
authors.lastname: Lecoeur
authors.affiliation: Univ Lille Nord de France, UDSL, EA GRITA 7365, UFR Pharmacy, 59006 Lille, France; Department of Pharmacy, University Hospital, Lille, France.
authors.forename: Bertrand
authors.initials: B
authors.lastname: Decaudin
authors.affiliation: Univ Lille Nord de France, UDSL, EA GRITA 7365, UFR Pharmacy, 59006 Lille, France.
authors.forename: Yoann
authors.initials: Y
authors.lastname: Guillotin
authors.affiliation: Department of Pharmacy, University Hospital, Clermont-Ferrand, France; EA 4676 C-Biosenss, Auvergne University, Clermont-Ferrand, France.
authors.forename: Valérie
authors.initials: V
authors.lastname: Sautou
authors.affiliation: Univ Lille Nord de France, UDSL, EA GRITA 7365, UFR Pharmacy, 59006 Lille, France.
authors.forename: Claude
authors.initials: C
authors.lastname: Vaccher
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods; D025924:Chromatography, Supercritical Fluid / Q000379:methods; D004864:Equipment and Supplies; D008027:Light; D010968:Plasticizers / Q000032:analysis*; D012542:Scattering, Radiation
chemical_list: D010968:Plasticizers
keywords: Evaporative light scattering detector; Liquid chromatography; Plasticizers; Porous graphitic carbon; Supercritical fluid chromatography; Validation