Abstract:

Teicoplanin-bonded chiral stationary phase was prepared and used for the direct chiral separation of racemic pantoprazole sodium by reversed-phase high performance liquid chromatography (HPLC). The influences of organic modifiers, the composition of mobile phase, the flow rate and column temperature on enantioseparation were studied. It was found that methanol was preferred than acetonitrile when used as organic modifier. With the increase of column temperature, chiral solutes were less retained and the separation factor value decreased indicating that lower temperature was better for the enantioseparation. Better resolution was obtained at lower flow rates as a result of minimization of the resistance of mass transfer. Based on these experimental data, the chiral HPLC method for the analysis of pantoprazole sodium on prepared chiral column (150 mm×4.6 mm i.d.,5 μm) was established with simplicity and good reproducibility, by using methanol-water (35∶65, v/v) as mobile phase at a flow rate of 0.6 mL/min and 20 ℃.

Key words: pantoprazole sodium , chiral stationary phase, enantioseparation, teicoplanin, reversed-phase high performance liquid chromatography (RP-HPLC)