| HPLC测定吗替麦考酚酯的含量 |
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| 引用本文： | 吴雪荣,陈琏.HPLC测定吗替麦考酚酯的含量[J].海峡药学,2010,22(8):97-99. |
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| 作者姓名： | 吴雪荣 陈琏 |
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| 作者单位： | 1. 广东潮州市潮州医院药剂科,潮州,521011
2. 广东潮州市药品检验所,潮州,521000 |
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| 摘 要： | 目的建立测定吗替麦考酚酯含量及有关物质的高效液相色谱方法。方法采用AgilentXDB-C色谱柱（4．6nm×150mm，5μm），流动相为乙腈-0．1％三氟醋酸溶液（三乙胺调节pH至3．9）（35：65），流速：1．0mL·min^-1.检测波长：250nm。结果各中间体及各降解产物均可与吗替麦考酚酯主峰良好分离。HPLC测定的线性范围为4．9—157．2mg·L^-1r=0．9999。方法的日内与日间精密度RSD分别为0．65％和1．02％。结论采用HPLC测定吗替麦考酚酯的含量及有关物质．方法简便．结果准确可靠。
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| 关 键 词： | 吗替麦考酚酯 含量测定 高效液相色谱法 |
Determination of Mycophenolate Mofetil content by HPLC |
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| WU Xue-rong,CHEN Lian.Determination of Mycophenolate Mofetil content by HPLC[J].Strait Pharmaceutical Journal,2010,22(8):97-99. |
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| Authors: | WU Xue-rong CHEN Lian |
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| Institution: | 1 .Guangdong Pharmacy Department of Chaozhou Hospital, Chaozhou, 521011, China;2. Guangdong Chaozhou Institute for Drug Control , Chaozhou, 521000, China) |
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| Abstract: | OBJECTIVE To develop a HPLC method for the determination of mycophenolate mofetil and its related sub-stances. METHODS Theseparation was perform ed on an Agilent XDB-C8 column（4.6nm×150mm,5μm）, and the mobilephase consisted of acetonitriie and 0.1% trifluoroacetic acid solution（adjusted to pH 3.9 with triethylamine）（35：65）at the flow rate of 1.0mL·min^-1. The detection was carried out at 250nm. RESULTS An excellent separation was achieved for mycophenolate mofetiland its related substances. The method was validated in the concentration range of 4.9--157.2mg· L^-1, （r= 0. 9999）. The RSDS of intraday and interday precision were 0.65% and 1.02% .CONCLUSION The method developed is successfully used to determinemycophenolate mofetil and its related substances. |
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| Keywords: | Mycophenolate mofetil Assay HPLC |
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