title: Determination of tris(2-ethylhexyl)trimellitate released from PVC tube by LC-MS/MS.
abstract: Tris(2-ethylhexyl)trimellitate (TOTM) is used as an alternative plasticizer of polyvinyl chloride (PVC) medical devices. A method for the determination of TOTM released from PVC medical devices into intravenous preparations was developed, which uses liquid chromatography-tandem mass spectrometry (LC-MS/MS). A PVC tube was filled with an intravenous preparation and extraction was carried out by shaking for 1h at room temperature. LC was performed with an Inertsil-C8 (50 mm x 2.1 mm, 5 microm) column. The isocratic mobile phase was acetonitrile:purified water (90:10, v/v) at a flow rate of 0.2 ml/min. MS detection was accomplished with an MS/MS detector equipped with a turbo ionspray ionization source in the positive ion mode. The limit of detection and the limit of quantification for the standard solution of TOTM was 0.5 ng/ml (S/N=3) and 1.0 ng/ml (S/N > or =10), respectively. When Prograf (tacrolimus) was used, the average recovery of TOTM was 101.1% (R.S.D.=4.72%; n=3). When our method was applied to the determination of TOTM released from unsterilized and gamma-ray-sterilized PVC tubes, we found that a higher concentration of TOTM was released from the unsterilized PVC tube than from the gamma-ray-sterilized one.
authors.affiliation: Department of Analytical Chemistry, Hoshi University, 2-4-41 Ebara, Tokyo 142-8501, Japan.
authors.forename: Rie
authors.initials: R
authors.lastname: Ito
authors.forename: Naoko
authors.initials: N
authors.lastname: Miura
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Iguchi
authors.forename: Hiroko
authors.initials: H
authors.lastname: Nakamura
authors.forename: Masaru
authors.initials: M
authors.lastname: Ushiro
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Wakui
authors.forename: Keisuke
authors.initials: K
authors.lastname: Nakahashi
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Iwasaki
authors.forename: Koichi
authors.initials: K
authors.lastname: Saito
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Suzuki
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Nakazawa
mesh_terms: D001565:Benzoates / Q000032:analysis* / Q000528:radiation effects; D002853:Chromatography, Liquid; D005720:Gamma Rays; D013058:Mass Spectrometry; D019999:Pharmaceutical Solutions; D011143:Polyvinyl Chloride / Q000032:analysis* / Q000528:radiation effects; D012015:Reference Standards; D015203:Reproducibility of Results; D012996:Solutions; D013242:Sterilization
chemical_list: D001565:Benzoates; D019999:Pharmaceutical Solutions; D012996:Solutions; C036101:tri-(2-ethylhexyl)trimellitate; D011143:Polyvinyl Chloride