HP-β-CD手性添加剂反相高效液相色谱拆分盐酸帕洛诺司琼S,R异构体  

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

作　　者：王嘉林 王斯坦 

机构地区：[1]洛阳市食品药品检验所,河南洛阳471023 [2]无锡瑞年实业有限公司

出　　处：《中国药师》2015年第2期237-240,共4页China Pharmacist

摘　　要：目的:以HP-β-环糊精为手性流动相添加剂,在RP-HPLC模式下建立盐酸帕罗诺司琼的异构体分析方法方法:采用资生堂CAPCELL PAK C18VG120(250 mm×4.6 mm,5μm)色谱柱,流动相为三乙胺(TEA)与不同浓度羟丙基-β-环糊精混合,通过乙酸调节p H,检测波长240 nm,柱温30℃,通过优化不同浓度的羟丙基-β-环糊精与p H,及流速,优化最佳分离条件。结果:最终确定以0.5%三乙胺(1%羟丙基-β-环糊精,用乙酸调节p H至5.5)-乙腈(85∶15)为流动相,流速0.5 ml·min-1,进样量10μl的色谱条件作为分离手段。盐酸帕罗诺司琼S,R异构体与主成分在手性添加剂作为流动相条件下分离良好。结论:该方法可以作为盐酸帕罗诺司琼光学异构体检查控制方法。Objective： To establish an HPLC method for the separation of optical isomers of palonosetron hydrochloride by RPHPLC with HP-β-cyclodextrin（ HP-β-CD） as the chiral additive. Methods： The optimal separation process was performed on a Shiseido CAPACELL PAK C18 VG 120（ 250 mm × 4. 6 mm,5 μm） column,the mobile phase was triethylamine（ TEA） with HP-β-CD at different concentrations,the p H value was adjusted by acetic acid,the detection wavelength was 240 nm,and the column temperature was 30℃. Results： The mobile phase was 0. 5% TEA（ 1% HP-β-CD,adjusting p H to 5. 5 with acetic acid）-acetonotirile（ 85∶ 15）;the detection wavelength was 240 nm,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.

关 键 词：高效液相色谱 手性 盐酸帕罗诺司琼 羟丙基-Β-环糊精 

分 类 号：R917[医药卫生—药物分析学]