Determination of Miglitol by Column-Switching Ion-Pair HPLC with Tris(2,2'-bipyridine)ruthenium(II)-Electrogenerated Chemiluminescence Detection.

We have developed a highly sensitive, simple method for the quantitative determination of miglitol in standard serum samples using column-switching ion-pair HPLC with tris(2,2'-bipyridine)ruthenium(II)-electrogenerated chemiluminescence detection. The serum samples were directly injected into a column-switching HPLC system with a Shim-pack MAYI-SCX precolumn to remove the serum matrix. Chromatographic separation of miglitol was achieved on a TSKgel ODS 100-V column using a mobile phase containing sodium 1-octanesulfonate as an ion-pair reagent. The detection and quantification limits of miglitol were 3 and 10 ng/mL, respectively. The calibration curve for miglitol in the serum samples showed good linearity (r(2)=0.9997) in the range of 10-2500 ng/mL. The recovery rate of miglitol from the serum samples was more than 94% as calculated from blank serum samples spiked with miglitol 50, 100, 500, 1000, and 2000 ng/mL. Therefore, this method can be applied to routine therapeutic monitoring of miglitol in serum samples.