Quantitative determination of voglibose in pharmaceutical tablets using high-performance liquid chromatography-fluorescence detection with post-column derivatization and mass spectrometric detection.

摘要

A highly sensitive liquid chromatographic procedure with post-column derivatization using fluorescence detection (LC-FD) was developed and validated for the determination of voglibose in pharmaceutical tablets. Sample pre-treatment included a simple extraction and centrifugation without pre-column derivatization. Taurine and sodium periodate dissolved in water was used as a post-column reagent. Detection was performed at an excitation wavelength of 350 nm and an emission wavelength of 430 nm. LC separation was carried out in less than 25 min. In addition to the LC procedure with post-column derivatization, an LC-MS assay procedure was also investigated for the analysis of voglibose without derivatization. Voglibose was detected in an electrospray ionization (ESI) mode with single ion recording (SIR, m/z 268.1). After selection of the optimum conditions, both assay methods were validated, providing good performances with respect to precision, linearity and accuracy. Linearities of both methods were obtained with an average r(2)>0.999. The lower limits of detection (LLOD) were 9.4 and 18 ng/ml for LC-FD and LC-MS, respectively. Both methods could be successfully applied to the quantification of voglibose in commercially available tablets.