| 高效液相色谱法测定非那雄胺片的含量及含量均匀度 |
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| 引用本文： | 何选林,王群英.高效液相色谱法测定非那雄胺片的含量及含量均匀度[J].中国药业,2008,17(11):25-26. |
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| 作者姓名： | 何选林 王群英 |
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| 作者单位： | 湖南省永州市药品检验所,河南,永州,425106 |
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| 摘 要： | 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。
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| 关 键 词： | 非那雄胺片 高效液相色谱法 含量测定 含量均匀度 |
| 文章编号： | 1006-4931(2008)11-0025-02 |
| 修稿时间： | 2007年9月20日 |
Determination of Assay and Content Uniformity of Finasteride Tablets by HPLC |
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| He Xuanlin,Wang Qunying.Determination of Assay and Content Uniformity of Finasteride Tablets by HPLC[J].China Pharmaceuticals,2008,17(11):25-26. |
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| Authors: | He Xuanlin Wang Qunying |
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| Institution: | (Yongzhou Municipal Institute for Drug Control, Yongzhou, Henan, China 425106) |
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| Abstract: | 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. |
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| Keywords: | finasteride tablets HPLC determination content uniformity |
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