High speed and precise evaluation of quality and physicochemical properties of pharmaceuticals by employing micro-analytical system such as CE

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We focused on capillary electrophoresis (CE) and ultra high-performance liquid chromatography (UHPLC), instead of the conventional HPLC, high speed and precise evaluation of quality and physicochemical properties of pharmaceuticals were investigated. Eenantiomers of diltiazem and its analogues etc. were successfully separated simultaneously by CE with dextrin as a chiral selector. Three enantiomers (e.g., six peaks) were separated within 15 min. By employing fluorescence detection in CE, high sensitive enantiomer separations of some DL-amino acids such as DL-Asp, DL-Ala were achieved. 4-Nitro-2,1,3-benzoxadiazole (e.g. NBD-F) was use as a derivatization reagent. In the separation by UHPLC, employing core-shell type columns, simultaneous separations of 6 cold medicines and 6 non-steroidal anti-inflammatory drugs (NSAIDs), 10 water soluble vitamins etc. were achieved within approximately 5 min with a relatively lower column pressure, compared with the conventional UHPLC columns.