title: Analysis of phthalate contamination in infusion solutions by automated on-line in-tube solid-phase microextraction coupled with high-performance liquid chromatography.
abstract: Contamination of infusion solutions with phthalates was analyzed, and its origin was determined. Phthalates were determined by on-line in-tube solid-phase microextraction coupled with high-performance liquid chromatography (in-tube SPME-HPLC) with UV detection. In-tube SPME is an extraction technique for organic compounds in aqueous samples, in which analytes are extracted from the sample directly into an open tubular capillary by repeated draw/eject cycles of sample solution. The infusion solutions were used without any pretreatment, and the phthalates in these solutions were automatically analyzed by the on-line in-tube SPME-HPLC system. The limits of detection of phthalates in the infusion solutions were 1-10 ng/mL. With a few exceptions, the recoveries of phthalates added to the infusion solutions were above 80%. Di-n-butyl phthalate (DBP) was detected at a concentration of 7-60 ng/mL in most infusion solutions in plastic containers but was not detected in those in glass bottles. On the other hand, no other phthalates were detected in infusion solutions in either plastic or glass containers. Large amounts of DBP were detected in the adhesive used to affix the paper labels to the plastic bottles and bags, but not in the plastic containers themselves. Furthermore, DBP was shown to be readily eluted from the adhesive into water and alcohol and easily pass through the plastic. These results indicated that the source of the DBP was the adhesive used to affix the paper labels, and DBP contaminated the infusion solutions by passing through the plastic. The in-tube SPME-HPLC method is simple and rapid and provides a useful tool for the screening and determination of phthalate contamination in infusion solutions.
authors.affiliation: School of Pharmacy, Shujitsu University, Nishigawara, Okayama 703-8516, Japan.
authors.forename: Kurie
authors.initials: K
authors.lastname: Mitani
authors.forename: Fumio
authors.initials: F
authors.lastname: Izushi
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Kataoka
mesh_terms: D000269:Adhesives / Q000737:chemistry*; D001331:Automation; D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation / Q000379:methods; D003993:Dibutyl Phthalate / Q000032:analysis*; D004340:Drug Contamination; D007260:Infusion Pumps; D010539:Permeability; D019999:Pharmaceutical Solutions / Q000032:analysis*; D010795:Phthalic Acids / Q000032:analysis*; D010969:Plastics / Q000737:chemistry; D012408:Rubber / Q000737:chemistry
chemical_list: D000269:Adhesives; D019999:Pharmaceutical Solutions; D010795:Phthalic Acids; D010969:Plastics; D003993:Dibutyl Phthalate; C032279:phthalic acid; D012408:Rubber