高效液相色谱法测定非那雄胺片的溶出度

Determination the Dissolution of Finasteride Tablets by HPLC

目的 采用高效液相色谱法测定非那雄胺片的溶出度。方法 高效液相色谱法。色谱柱为LUNA 5 μmC18(2 ) (15 0×4 .6 0mm ,U .S .A) ,流动相为 2 .5mmol·L-1磷酸溶液 -乙腈 (1∶1) ,检测波长 2 2 0nm。结果 非那雄胺的最低检出量约为 2ng ;非那雄胺在 1.4～ 16 .8μg·ml-1(r =0 .9999)范围内 ,峰面积与其浓度呈良好线性关系 ,平均回收率为 99.6 1% ,RSD为 1.0 5 % (n=6 )。结论 分析速度快 ,简单 。

Aim To develop an HPLC method for determining the dissolution of finasteride tablets.Methods High performance liquid chromatography isused.The chromatographic column is LUNA 5μm C 18 (2)(150×4.60mm,U.S.A),the mobile phase is 2.5mmol·L -1 phosphoric acid-acetonitrile (1∶1),and wavelength is 220nm.Results The detection limit was about 2ng for finasteride.The calibration curve is linear in the range of 1.4～16.8μg·ml -1 (r=0.999 9) for finasteride.The average recovery is 99.61% with RSD=1.05%(n=6).Conclusion This method is simple,quick and accurate.