Current applications in the analysis of pharmaceuticals by capillary electrophoresis. I

The current role of capillary electrophoresis (CE) in the analysis of pharmaceuticals has been reviewed. This article covers the use of CE for main component determinations, stoichiometric assays, analysis of vitamins and regulatory aspects. Several of these reports have shown successful validation of CE methods for main component assays, stoichiometric determinations and vitamin analysis. Methods have been shown to have good sensitivity, linearity (correlations > 0.999) with relative standard deviation (RSD) values of 0.3-2% for peak area ratios. Excellent crosscorrelation data have been obtained when CE data have been compared to that of other techniques such as HPLC. This review also includes data from the regulatory authorities. The attitude of regulatory authorities towards this relatively new technique is of paramount concern to workers in the field of pharmaceutical analysis. It is generally agreed that CE has been well received by regulatory bodies and this has served to stimulate growth and interest in CE within the pharmaceutical industry. Part II covers the use of CE to determine drug-related impurities, chiral separations and the growing use of capillary electrochromatography in pharmaceutical analysis. (C) 1998 Elsevier Science B.V.