Optimization of Hydrophilic-Lipophilic Balance Solid-Phase Extraction of Phthalates in Pharmaceutical Preparations

Abstract

Phthalates, which are used as plasticizers to soften rough polymers in the industrial processes, possess endocrine system disrupting activities. In this study, a hydrophilic-lipophilic balance solid-phase extraction method was optimized for seven phthalates as dimethyl, dipropyl, benzyl butyl, di-n-butyl, dicyclohexyl, di-(2-ethylhexyl) and di-n-octyl phthalates in terms of the type and the volume of the conditioning and elution solvents. The phthalates were quantified by a validated HPLC/UV method. The recovery values were higher than 80% for dimethyl, dipropyl, benzylbutyl, di-n-butyl and dicyclohexyl phthalates. Using the optimized conditions three types of liquid pharmaceutical preparations as an intravenous isotonic sodium chloride solution, an intravenous dextrose solution and an osmotic laxative kept in polymeric packages were analyzed with high accuracy, precision and recovery. Only the intravenous isotonic sodium chloride solution was determined to be contaminated with dipropyl phthalate at a concentration of 13.2 μg/L.

Keywords

• Hydrophilic-lipophilic balance,high performance liquid chromatography,pharmaceutical,phthalate,solid-phase extraction

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