The validation of column-switching LC/MS as a high-throughput approach for direct analysis of di(2-ethylhexyl) phthalate released from PVC medical devices in intravenous solution

Health Canada reported recently that medical devices containing di(2-ethylhexyl) phthalate (DEHP) should not be used in the clinical treatment of infants, young boys, pregnant women, and nursing mothers. The risk assessment of DEHP released from PVC medical devices is an important issue for hospital...

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Veröffentlicht in:Journal of pharmaceutical and biomedical analysis 2003-04, Vol.31 (6), p.1145-1152
Hauptverfasser: Inoue, Koichi, Higuchi, Tae, Okada, Fumio, Iguchi, Hirofumi, Yoshimura, Yoshihiro, Sato, Atsushige, Nakazawa, Hiroyuki
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container_end_page 1152
container_issue 6
container_start_page 1145
container_title Journal of pharmaceutical and biomedical analysis
container_volume 31
creator Inoue, Koichi
Higuchi, Tae
Okada, Fumio
Iguchi, Hirofumi
Yoshimura, Yoshihiro
Sato, Atsushige
Nakazawa, Hiroyuki
description Health Canada reported recently that medical devices containing di(2-ethylhexyl) phthalate (DEHP) should not be used in the clinical treatment of infants, young boys, pregnant women, and nursing mothers. The risk assessment of DEHP released from PVC medical devices is an important issue for hospitalized patients. In this study, a simple, accurate, low-contamination and high-throughput analytical technique for the determination of DEHP in intravenous (IV) solution was developed using column-switching liquid chromatography/mass spectrometry (LC/MS) with an extraction mini-column. The sample preparation for on-line extraction involved simply mixing IV solution with internal standard as DEHP-d 4 in LC glass vials. The IV fat emulsion drug sample cannot be analyzed directly, hence this sample spiked with DEHP-d 4 solution was extracted by hexane and measured by column-switching LC/MS yielding an average recovery of 92.2% (C.V.=7.8%, n=5). A linear response was found for a variety of drugs tested within the validated range of 0.1 or 0.5–10 μg/ml with correlation coefficients ( r) greater than 0.99. These results suggest that this method can assay background exposure to DEHP released from PVC medical devices in the patients. The method was applied to various IV solution samples to establish the first screening method for DEHP released from medical devices with respect to their safety.
doi_str_mv 10.1016/S0731-7085(03)00019-0
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subjects Biological and medical sciences
Biotechnology
Chromatography, High Pressure Liquid - methods
Column-switching
DEHP
Di(2-ethylhexyl)phthalate
Diethylhexyl Phthalate - analysis
Diethylhexyl Phthalate - pharmacokinetics
Equipment and Supplies - standards
Fundamental and applied biological sciences. Psychology
Health. Pharmaceutical industry
Industrial applications and implications. Economical aspects
Infusions, Intravenous
Intravenous (IV) solution
LC/MS
Miscellaneous
Pharmaceutical Solutions - analysis
Pharmaceutical Solutions - pharmacokinetics
Polyvinyl Chloride - analysis
Polyvinyl Chloride - pharmacokinetics
PVC medical devices
Spectrometry, Mass, Electrospray Ionization - methods
title The validation of column-switching LC/MS as a high-throughput approach for direct analysis of di(2-ethylhexyl) phthalate released from PVC medical devices in intravenous solution
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