ROUTINE CAPILLARY ELECTROPHORESIS TRACE-LEVEL DETERMINATIONS OF PHARMACEUTICAL AND DETERGENT RESIDUES ON PHARMACEUTICAL MANUFACTURING EQUIPMENT

Capillary electrophoresis methods are reported for the determination o f trace levels of substances possibly present as contaminants on equip ment used in pharmaceutical manufacturing. A previously reported metho d for the determination of a range of basic drugs was optimised throug h use of internal standards and a shorter length capillary. This metho d was used to establish an optimised extraction procedure through anal ysis of solutions containing a range of drugs with different solubilit ies. A CE method for the trace level analysis of a range of different acidic drugs was shown to be capable of achieving acceptable precision and sensitivity. Levels of detergent solution residue were monitored by quantifying potassium levels using indirect UV detection. These met hods are in routine use within our laboratories.