Abstract
The potential deleterious effects of extractables/leachables in pharmaceutical products and the need to preserve product safety throughout its shelf life have led the three major pharmacopoeias (USP, EP, JP) to require extractable and toxicity testing of container/closure systems. To that, a HPLC/UV method was developed and validated for the detection of zinc dibutyl dithiocarbamate (ZDBC) as potential extractable from pharmaceutical container closure system of eye drops solutions. The method consists of direct extraction of the analyte with chloroform; the lower layer was evaporated to dryness and further reconstituted with acetonitrile. The chromatographic separation was performed on a Nova-Pak C18 column using as mobile phase a mixture of acetonitrile:water. Calibration curves were linear and relative standard deviation was sufficient. Detection limit of ZDBC was found to be 0.015 μg/mL. The HPLC method was further applied in seven currently marketed eye drops solutions, confirming its applicability for monitoring dithiocarbamates migration from container closure systems into the eye drops solutions.
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