S, R-Isomer Separation of Hydrochloride Palonosetron by RP-HPLC with HP-β-CD as Chiral Additive / 中国药师

ABSTRACT

Objective: To establish an HPLC method for the separation of optical isomers of palonosetron hydrochloride by RP-HPLC with HP-β-cyclodextrin ( HP-β-CD) as the chiral additive. Methods:The optimal separation process was performed on a Shi-seido CAPACELL PAK C18 VG 120 (250 mm × 4. 6 mm,5μm) column,the mobile phase was triethylamine (TEA) with HP-β-CD at different concentrations, the pH value was adjusted by acetic acid, the detection wavelength was 240nm, and the column temperature was 30℃. Results:The mobile phase was 0. 5% TEA (1% HP-β-CD, adjusting pH to 5. 5 with acetic acid)-acetonotirile (85∶15);the detection wavelength was 240nm, and the flow rate was 0. 5 ml·min-1 . The S, R-Isomer of palonosetron hydrochloride could be well separated. Conclusion:The method can be used as the optical isomer quality control for palonosetron hydrochloride.