Studies On The Application Of HPCE In Pharmaceutical Analysis

Chapter1:In this chapter, the history of CE, the basic theories, the separation modes, the detections coupled with CE were briefly introduced. The application of CE on the analysis of ion, small molecules, food, environment, biological and medicine determinations were reviewed. The content and the meaning of the work were introduced, too.Chapter2:A high performance capillary electrophoresis (HPCE) method with diode array detection has been successfully developed for the determination of puerarin in Xinkeshu capsules and biological samples. The optimal conditions were determined to be70mM H3BO3-Na2B4O7, pH9.2, applied voltage25kV, working temperature25℃and detection wavelength254nm. Under these conditions, a linear range from17.3to138ng/mL with the correlation coefficient of0.9998and limit of detection of34.6ng/mL (S/N=3) for puerarin were obtained, the average recovery were97.4～103%and the relative standard deviation (RSD) were0.58～2.52%(n=5).The proposed method was successfully applied to analyze the puerarin content in Xinkeshu capsules and some biological samples with good results. It is suitable for applications in pharmaceutical industries for quality control and in clinical laboratories for therapeutic drug monitoring purposes.Chapter3:A simple method for the simultaneous determination of four bioactive components (puerarin, daidzein, rutin, and ferulic acid) in pharmaceutical and biological samples by capillary electrophoresis with diode array detection has been developed. The optimal conditions were determined to be50mM H3BO3-Na2B4O7, pH9, applied voltage25kV, working temperature25℃and detection wavelength254nm. Under these conditions, The relative standard deviations of the peak areas and the migration times of the analytes were in the range of1.11～2.88%and0.2～0.63%(intraday),1.16～2.1%and0.32～1.13%(interday), respectively. The detection limit (S/N=3) was4.77x10-6、2.21x10-7、7.25x10-7and6.11x10-6mg/mL for puerarin, daidzein, rutin, and ferulic acid, respectively. This method has been successfully applied to simultaneous determination of the four bioactive components.Chapter4:A high performance capillary electrophoresis (HPCE) method with diode array detection was established for the determination the contents of puerarin and daidzein in radix puerariae and naodesheng tablets. An uncoated fused-silica capillary (57cmx75μm, effective length50cm) was used.60mmol·L-1borax-borate buffer (pH9.0) was used as a running buffer, the applied voltage was25kV, the capillary temperature was controlled at25℃and the wavelength of detector was set at254nm. There is a good linear relationship between the peak areas and the concentration of the analytes in the range of0.2～1.2mg·mL-1for puerarin and0.1～0.6mg·mL-1for daidzein. the detection limit (S/N=3) for puerarin and daidzein were27.5ng·mL-1and12.7ng·mL-1, respectively, the method was simple, rapid, accurate and can be used to control puerarin and daidzein in radix puerariae and naodesheng tablets.