| HPLC法测定阿苯达唑胶囊的含量及有关物质 |
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| 引用本文： | 林晨,林伊莉.HPLC法测定阿苯达唑胶囊的含量及有关物质[J].海峡药学,2013(11):72-74. |
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| 作者姓名： | 林晨 林伊莉 |
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| 作者单位： | [1]福建省药品检验所,福州350001 [2]福建中医药大学09药物制剂,福州350122 |
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| 摘 要： | 目的建立HPLC法测定阿苯达唑胶囊的含量及有关物质。方法采用HPLC法，以Welch Ultimate XB．c18（4．6mm×200mm，5μm）为色谱柱；甲醇-水（70：30）为流动相；流速1．0mL·min^-1；检测波长295nm；进样量10μL。结果阿苯迭唑线性范围为5．032μg·mL^-1～-15．096Izg·mL^-1（r=0．9999）；回收率为100．7％（RSD：0．2％，n=9）；测定样品有关物质显示有较好的重复性和稳定性，各个杂质与主峰能完全分离，检测限是0．4825ng。结论本文方法简便、准确、快速、专属性好，适合于阿苯达唑胶囊的质量控制。
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| 关 键 词： | 阿苯达唑胶囊 含量测定 有关物质 高效液相色谱法 |
Determination of the content and related substances in Albendazole capsules by HPLC |
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| LIN Chen ; LIN Yi-li.Determination of the content and related substances in Albendazole capsules by HPLC[J].Strait Pharmaceutical Journal,2013(11):72-74. |
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| Authors: | LIN Chen ; LIN Yi-li |
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| Institution: | LIN Chen ; LIN Yi-li ( 1. Fujian Institute for Drug Control, Fuzhou 350001, China ;2. Fujian University of Traditional Chinese Medicine, Fuzhou 350122, China) |
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| Abstract: | OBJECTIVE To establish a method for the determination of the content and related substances in Albendazole eapsules by high performanee liquid chromatography （HPLC）. METHODS A satisfactory separation was obtained using Welch Ultimate XB-C18 with the mobile phase methanol-water（70： 30） at a flow rate 1.0mL . min^ -1 and the determination wavelength was 295nm. RESULTS The calibration curve of albendazole was linear in the ranges of 5.032μg . mL^-1 - 15.096 μg . mL^-1（ r = 0. 9999）. The average recovery was 100. 7% （RSD = 0. 2%, n = 9）. Albendazole and related substances could be well isolate＆ The detection limit was 0. 4825ng. CONCLUSION The method is validated in terms of seleetivity, accuracy and precision which is suitable for the quality control of Albendazole capsules. |
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| Keywords: | Albendazole eapsules Coment determination Related substanees HPLC |
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