High Performance Liquid Chromatography In The Analysis And Synthesis Of Three Nitrogen-containing Drugs

In this thesis, we studied the applying of High Performance Liquid Chromatography (HPLC) in the field of drug analysis and the optimization of drug synthetic routes for Betaxolol Hydrochloride, Clindamycin Phosphate and Sparfloxacin.The main work of this thesis was described as following. The first was to select a HPLC analytical condition and then to optimize it for the different analytical target. The second, we studied the systematic suitabilities of Betaxolol Hydrochloride and Sparfloxacin. By the work of this part, we proved the analytical methods that we established have a good accuracy and stability. Both were not only suitable for the analysis in the laboratory, but also simple and convenience for the quality control in the factory. The third, we optimized the synthetic routes of Betaxolol Hydrochloride and Clindamycin Phosphate by the use of HPLC. The fourth, we studied the stability of Betaxolol Hydrochloride. The data we got will be useful for the manufacture of the drug, as well as the quality control and its clinic use. The last, we had determined the content of Sparfloxacin injections quantitatively by HPLC, and also its purity.The main analytical conditions were shown as following. A Waters Symmetry CIS (5um,150mmx3.9mmI.D.)column and a TSKgel ODS-80TsQA (5um, 150mmx4.6mm I.D.) column were used as the analytical column. The column temperature was 30C. The injection volume was l0ul and the flow-rate was l.0ml/min. For BetaxololHydrochloride, the detective wavelength was UV-273.9nm. The mobile phase was 0.2?oKH2PO4(PH=2.55)-CH3OH-CH3CN (62:23:15). The theoretical plate of the Betaxolol Hydrochloride peak was 26000/m. For Clindamycin Phosphate, the detective wavelength was UV-210nm. The mobile phase was 0.2%KH2PO4(PH=2.50)- CH3CN (81:19). The theoretical plate of the Clindamycin Phosphate peak was 20000/m. For Sparfloxacin, the detective wavelength was UV-298.8nm. The mobile phase was 0.2%KH2PO4(PH=3.2)-CH3CN-CH3OH (80:15:5). The theoretical plate of the Sparfloxacin peak was 15300/m.