高效液相色谱法测定非那雄胺片的含量及含量均匀度

Determination of Assay and Content Uniformity of Finasteride Tablets by HPLC

目的探讨用高效液相色谱法测定非那雄胺片的含量及含量均匀度。方法采用Hypersil-ODS色谱柱(150mm×4.6mm,5μm),流动相为乙腈-用磷酸调pH值至4.5的0.02mol/L醋酸铵(55∶45),流速为1.0mL/min,检测波长为220nm,柱温为室温。结果回归方程为Y=35773.7+16501.6X,r=0.99996,平均回收率为99.6%,RSD=0.39%(n=6)。结论所用方法简便、可靠、快速,可用于非那雄胺片生产的质量控制。

Objective To establish the determination method of the assay and content uniformity for finasteride tablets by HPLC. Methods Hypersil-ODS column （150 mm×4.6 mm,5μm） was used with the detection wavelength at 220 nm. The mobile phase was acetonitrile- ammonium acetate （pH was adjusted to 4. 5 by phosphoric acid） （55：45）, The flow rate was 1.0 mL/min. Results The linear correlation was good in the range of 4 - 100 μg/mL, Y= 35 773.7 ＋ 16 501.6X, r =0. 999 96. The average recovery rate was 99.6% and RSD was 0.39% （n =6）. Conclusion The method is simple, reliable and rapid. It can be used for the quality control of finasteride tablets.