| 反相高效液相色谱法测定他克莫司胶囊的含量 |
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| 引用本文： | 郑国钢,管燕,罗金文. 反相高效液相色谱法测定他克莫司胶囊的含量[J]. 中国药业, 2007, 16(1): 17-18 |
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| 作者姓名： | 郑国钢 管燕 罗金文 |
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| 作者单位： | 1. 浙江省药品检验所,浙江,杭州,310004
2. 浙江省邵逸夫医院,浙江,杭州,310016 |
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| 摘 要： | 目的 探讨用反相高效液相色谱法测定他克莫司胶囊中他克莫司含量。方法 采用Agilem Zorbax XDB Cs色谱柱（150mm×4．6mm，5μm），流动相为乙腈-0．25％磷酸溶液（65：35），流速为1．0mL／min，检测波长为210nm。峰面积按外标法计算。结果 他克莫司质量浓度在100．1—1001．2μg／mL范围内与峰面积线性关系良好，r=0．9999，平均回收率为100．3％，RSD小于1．0％（n=9），日内和日间RSD分别为0．4％和0．9％。结论 反相高效液相色谱法简便、快捷、灵敏，可以作为他克莫司胶囊含量的测定方法。
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| 关 键 词： | 他克莫司胶囊 含量测定 反相高效液相色谱法 |
| 文章编号： | 1006-4931（2007）01-0017-02 |
| 收稿时间： | 2006-03-23 |
| 修稿时间： | 2006-06-07 |
Content Determination of Tacrolimus Capsules by HPLC |
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| Zheng Guogang,Guan Yan,Luo Jinwen. Content Determination of Tacrolimus Capsules by HPLC[J]. China Pharmaceuticals, 2007, 16(1): 17-18 |
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| Authors: | Zheng Guogang Guan Yan Luo Jinwen |
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| Affiliation: | Zheng Guogang, Guan Yan, Luo Jinwen( 1. Zhejiang Institute for Drug Control, Hangzhou, Zhejiang, China 310004; 2. Zhejiang Sir Run Run Shaw Hospital, Hangzhou, Zhejiang, China 310016) |
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| Abstract: | Objeefive To establish RP-HPLC method for the content determination of tacrolimus capsules. Methods Agilent Zorbax XDB C8 （150mm ×4.6 ram,5μm） was used as the stationary phase. The mobile phase was acetonitrile-0.25% H2PO4 （65：35）.The flow rate was 1.0 mL/min, and the detection wavelength was 210nm. Results The method was proved to be linear in the range of 100. 1 - 1001.2 μg/mL with a regression coefficient of 0. 9999. The average recovery rate was 100. 3% with RSD 〈 1.0% （n=9）. The RSD of average contents of intra- day and interday was 0. 4% and 0. 9% respectively. Conclusion The method is simple, rapid and accurate. It is suitable for the content determination of tacrolimus capsules. |
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| Keywords: | tacrolimus capsules content determination RP - HPLC |
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