Abstract # A-12

SIMULTANEOUS QUANTITATIVE RESOLUTION OF MIXTURES OF THREE TYPES OF LEACHABLE LATEX ACCELERATORS USING A REVERSED-PHASE HPLC METHOD. Ellen T. Chen and Leroy W. Schroeder. Division of Mechanics and Materials Science, CDRH, FDA, Rockville, MD 20857

Thiazole, thiuram disulphides and dithiocarbamate represent the three major types of skin irritants. A reversed-phase HPLC method has been developed for simultaneous quantitative resolution of mixtures of this three types of leachable accelerators from latex gloves. Analyte solutions with 0.1% of Na2 EDTA were stable and reduced interferences. The approach was evaluated by a photo diode array (PDA) and an electro-chemical detectors (LCEC) in series. Quantitative results of resolved individual component from mixtures are reported. Linear least-squares slope and intercept of determined vs prepared concentrations for zinc diethyl dithiocarbamate using the LCEC detector were 1.00±0.01 and 0.05±0.02 µg/mL for three runs on each of four samples in the concentration range from 0.01 to 8.0 Ág/mL with a rsd value of 1.1% for the average concentration. Similar results were obtained for thiazole and thiuram disulphides. The PDA detector gave similar results, except the LCEC detector can reach to 100-fold lower concentrations.

The four-component mixtures can be stored at room temperature for 24 h with the relative error coefficient (rec) less than 0.3%/h and 0.5%/h for the most unstable compound using the LCEC and the PDA detectors, respectively.