Abstract:

Vacomycin-bonded chiral stationary phase was used for the direct chiral separation of tenatoprazole enantiomers using reversed-phase high performance liquid chromatography (HPLC). The influences of the kinds and concentration of buffer and organic modifier, the pH value of buffer, column length and column temperature on the separation were examined. The chiral HPLC method for the separation of tenatoprazole enantiomers on a Chirobiotic V column (150 mm×4.6 mm, 5 μm) was established with simplicity and good reproducibility using 0.02 mol/L ammonium acetate buffer (pH 6.0)-tetrahydrofuran (93∶7, v/v) as the mobile phase at a flow rate of 0.5 mL/min and 20 ℃. Under the above conditions, the enantiomers were separated on baseline with the resolution of 1.68. The relative standard deviations （RSDs） for the retention times of tenatoprazole enantiomers were 0.48% and 0.49% (n=6). The RSDs for the peak areas of tenatoprazole enantiomers were 0.45% and 0.55% (n=6).

Key words: chiral separation, chiral stationary phase, tenatoprazole enantiomers , high performance liquid chromatography （HPLC）