| 关于紫杉醇注射液有关物质检查方法的探讨 |
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| 引用本文： | 张才煜,吴健敏,张启明. 关于紫杉醇注射液有关物质检查方法的探讨[J]. 中国药师, 2010, 13(9): 1310-1312 |
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| 作者姓名： | 张才煜 吴健敏 张启明 |
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| 作者单位： | 中国药品生物制品检定所,北京100050 |
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| 摘 要： | 目的：探讨国家标准紫杉醇注射液中有关物质检查的方法。方法：采用Agilent Zorbax Eclipse C18柱（250mm×4．6mm，5μm）；以乙腈．水为流动相进行梯度洗脱，流速为1．5ml·min^-1，柱温为30℃；检测波长为227nm。结果：采用改进后的方法对15个厂家的样品进行了有关物质的测定，分别对样品中的已知杂质、未知杂质及总杂质进行了定量。结论：改进后的紫杉醇注射液的有关物质检查方法更为合理。
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| 关 键 词： | 高效液相色谱法 紫杉醇注射液 有关物质 |
Discussion on the Method of Determination of Related Substances in Paclitaxel Injection |
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| Zhang Caiyu,Wu Jianmin,Zhang Qiming. Discussion on the Method of Determination of Related Substances in Paclitaxel Injection[J]. China Pharmacist, 2010, 13(9): 1310-1312 |
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| Authors: | Zhang Caiyu Wu Jianmin Zhang Qiming |
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| Affiliation: | (National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China) |
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| Abstract: | Objective： To discuss the HPLC method to determine the related substances of paclitaxe] injection in national stand- ard. Method： The Agilent Zorbax Eclipse Cl8 column （250 mm ×4. 6 mm,5 μm） was used. The mobile phase was consisted of acetonitrile and water with gradient elution. The flow rate was 1.5 ml. min- 1 ; the column temperature was 30 ℃, and the UV detector was set at 227 nm. Result： The related substances from fifiteen manufactures were determined by the revised method. Conclusion： The revised method is more reasonable. |
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| Keywords: | HPLC Paclitaxel Injection Related substances |
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