Solid-Phase Extraction and Liquid Chromatographic Determination of Monophthalates and Phthalide ExtractedFrom Solution Administration Sets

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Abstract
A liquid chromatographic procedure is described for the determination of phthalide, monobutyl phthalate, and mono-2-ethylhexyl phthalate leached by water from solution administration sets. Recoveries varied from 88.8% for phthalide at 1 (μg/50 mL to 113% for monobutyl phthalate at 6 μg/50 mL. Relative standard deviations at 1 μg/50 mL were 2.59% for phthalide, 3.54% for monobutyl phthalate, and 11.6% for mono-2- ethylhexyl phthalate. At 6 μg/50 mL, the relative standard deviation for mono-2-ethylhexyl phthalate decreased to 3.88%. Reproducibilities for 5 standard injections were 1.40% for phthalide, 1.84% for monobutyl phthalate, and 1.95% for mono-2- ethylhexyl phthalate. Correlation coefficients were 1.00 for the 3 compounds. Five sets from 2 manufacturers were examined. No phthalide or monobutyl phthalate was found. One manufacturer’s sets contained 37.6-44.4 μg/L mono-2- ethylhexyl phthalate. The sample matrix had some interference if phthalide or monobutyl phthalate was present.

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