Phthalates determination in pharmaceutical formulae used in parenteral nutrition by LC-ES-MS: importance in public health


A method for determining a group of phthalate esters in pharmaceutical formulae used in parenteral nutrition samples (with and without vitamins) has been developed. The phthalic acid esters (PAEs) studied were dimethyl phthalate, diethyl phthalate, butyl benzyl phthalate, dibutyl phthalate, di-(2-ethylhexyl) phthalate, and dioctyl phthalate. This group of phthalates was determined by high performance liquid chromatography (HPLC)–electrospray ionization–mass spectrometry, working in positive ion mode. The phthalates analyzed were extracted from the sample using hexane and sodium hydroxide. The hexane was then evaporated, and the compounds were redissolved in acetonitrile. The compounds were separated by HPLC working in gradient mode with acetonitrile-ultrapure water starting from 5% to 75% acetonitrile in 5 min, followed by isocratic elution for 27 min. Standard calibration curves were linear for all the analytes over the concentration range 10–250 µg L−1. The method was precise (with RSD from 3.3% to 12.9%) and sensitive. The proposed analytical method has been applied to the analysis of these compounds in different pharmaceutical formulae (with different compositions) for parenteral nutrition samples in order to check the presence of phthalates and determine their concentration.

Parenteral nutrition sample stored in an ethyl vinyl acetate bag.

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The authors wish to thank the Xunta de Galicia (Grupo de Referencia Competitivos 2007 (000047-0)) for financial support. We are also grateful to the Neonatology Service and the Pharmacy Department from Complejo Hospitalario Universitario de Santiago, CHUS, for supplying the parenteral nutrition. Cristina Pérez Feás wishes to thank the Ministerio de Educación y Ciencia for her FPU grant.

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Correspondence to Pilar Bermejo-Barrera.

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Pérez-Feás, C., Barciela-Alonso, M.C., Sedes-Díaz, A. et al. Phthalates determination in pharmaceutical formulae used in parenteral nutrition by LC-ES-MS: importance in public health. Anal Bioanal Chem 397, 529–535 (2010).

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  • Phthalates
  • LC-ES-MS
  • Parenteral nutrition