INVESTIGADORES
VIZIOLI nora Matilde
congresos y reuniones científicas
Título:
Purity assessment of synthetic peptides by on-line capillary electrophoresis
Autor/es:
VIZIOLI NM; RUSELL ML; GUZMAN NA; CARDUCCI CN
Lugar:
Cartagena de Indias, Colombia
Reunión:
Congreso; IX Congreso Latinoamericano de Cromatografía y Técnicas Afines, COLACRO IX; 2002
Resumen:
During the last decade a growing demand of peptides as therapeutic agents and diagnostics has progressively required a more exigent control on their purity from regulatory agencies.  Many advances have been made in manufacturing areas to obtain final drug products with high levels of quality.  The analysis of potential impurities that may be present in a peptide drug becomes relevant, requesting highly selective and sensitive analytical methodologies. The on-line preconcentration capillary electrophoresis method presented in this work was optimized, validated and applied to the control purity of biologically active synthetic peptides.  The laboratory-made devices of the analyte concentrator cartridge were packed with silica-based C18 reversed-phase chromatographic material.  All solutes were introduced by hydrodinamic mode, and the column was washed and equilibrated with separation buffer.  The desorption step was performed with an acetonitrile:buffer solution (75:25, vol/vol) and the components were monitored at 214 nm. The method proposed allowed the preconcentration and separation of impurities from a main component with an increase sensitivity of 100 to 200 fold.  A remarkable improving in selectivity and resolution respect to conventional capillary zone electrophoresis was achieved.  Figures of merit such as linearity range, intra- and inter-day precision and robustness were assayed. In order to evaluate the impurity profiles under study, other electrophoretic systems were proved specially those compatible with mass spectrometry detection. The results obtained emphasize the employment of on-line preconcentration capillary electrophoresis for purity testing of synthetic peptides.