QUANTITATIVE-ANALYSIS OF RESIDUAL SYNTHETIC POLYSTYRENE ADSORBENT IN DRUGS BY CURIE-POINT PYROLYSIS-GAS CHROMATOGRAPHY

Residual synthetic adsorbent, cross-linked polystyrene, used in drug p urification has been analyzed quantitatively by Curie-point pyrolysis gas chromatography. The peaks of intact polystyrene adsorbent in the p yrogram were used as key peaks for quantitative measurement of residue s of the adsorbent in vitamin B-1 and streptomycin sulfate. It was sho wn that the m-ethylstyrene or p-ethylstyrene peaks in the pyrolyzates were suitable for determination of polystyrene adsorbent content. The levels of residual adsorbent in the drugs were found to be < 0.1 %, th e value stipulated by the International Conference on Harmonization (I CH). In quantitative evaluation of an adsorbent content of 0.1 % the p recision was 3.6 % and 2.7 % for vitamin B-1 and streptomycin sulfate, respectively.