Determination of tris(2-ethylhexyl)trimellitate released from PVC tube by LC-MS/MS.
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.
Ito
Rie
R
Department of Analytical Chemistry, Hoshi University, 2-4-41 Ebara, Tokyo 142-8501, Japan.
Miura
Naoko
N
Iguchi
Hirofumi
H
Nakamura
Hiroko
H
Ushiro
Masaru
M
Wakui
Nobuyuki
N
Nakahashi
Keisuke
K
Iwasaki
Yusuke
Y
Saito
Koichi
K
Suzuki
Tsutomu
T
Nakazawa
Hiroyuki
H
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
D001565:Benzoates; D019999:Pharmaceutical Solutions; D012996:Solutions; C036101:tri-(2-ethylhexyl)trimellitate; D011143:Polyvinyl Chloride