非那甾胺中5β-异构体的HPLC分离与测定

Isolation and determination of 5β-isomer in Finasteride by HPLC

目的 分离和测定非那甾胺中5β-异构体杂质。方法 高效液相色谱法,色谱柱为DiamonsilTMC18柱(4.6 mm×200 mm,5μm),流动相为乙腈-四氢呋喃-水(3:1:8),流速为1.5 mL·min-1,检测波长为210nm,柱温25℃。结果 非那甾胺与5β-异构体能有效分离,两者最低检测浓度均为0.05μg·mL-1。结论 本法操作简便,重现性好,可有效控制非那甾胺的质量。

OBJECTIVE To isolate and determine 5β-isomer of Finasteride by HPLC. METHODS A Diamonsil?C18 column was used, with the mobile phase of acetonitrile-tetrahydrofuran-water (3 : 1 : 8) . The flow rate was 1. 5 mL· min-1 , the detection wavelength was 210 nm, and the column temperature was 25. RESULTS 5β-isomer and Finasteride could be isolated exactly. The lowest determining concentration of both was 0. 05 ·g · mL-1 . CONCLUSIONS The method is simple and reproducible, and the quality of Finasteride can be controlled effectively.