| HPLC法测定沙纳唑的含量及其有关物质 |
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| 引用本文： | 尹华,吴建敏,俞如英,黄荣清,骆传环.HPLC法测定沙纳唑的含量及其有关物质[J].药物分析杂志,2003,23(4):310-312. |
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| 作者姓名： | 尹华 吴建敏 俞如英 黄荣清 骆传环 |
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| 作者单位： | 中国药品生物制品检定所，中国药品生物制品检定所，中国药品生物制品检定所，军事医学科学院放射医学研究所，军事医学科学院放射医学研究所 北京 100050，北京 100050，北京 100050，北京 100850，北京 100850 |
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| 摘 要： | 目的:建立高效液相色谱法测定沙纳唑的含量及其有关物质。方法:采用 Kromasil KR 100 C_(18)色谱柱(4.6 mm×250mm,5μm)。流动相:甲醇-水-冰醋酸(200:800:3),流速:1 mL·min~(-1)。检测波长:248 nm。结果:HPLC法测定的线性范围为50～300μg·mL~(-1),r=0.9999,最低检测限为0.5 ng,本方法重复性和精密度良好(RSD<2％)。结论:采用HPLC法测定沙纳唑及其注射液的含量及有关物质,方法简便,结果准确。
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| 关 键 词： | 沙纳唑 放疗增敏剂 含量测定 有关物质 高效液相色谱法 |
HPLC Determination of Content of Sanazole and Its Related Substances |
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| YIN Hua,WU Jian -min,YU Ru -ying,HUANG Rong -qing and LUO Chuan -huan.HPLC Determination of Content of Sanazole and Its Related Substances[J].Chinese Journal of Pharmaceutical Analysis,2003,23(4):310-312. |
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| Authors: | YIN Hua WU Jian -min YU Ru -ying HUANG Rong -qing and LUO Chuan -huan |
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| Abstract: | Objective:To establish HPLC method for determination of sanazole content and its related substances. Methods: Kromasil KR100 - C18column(4. 6 mm x250 mm,5 um) with methanol - water - glacial acetic acid(200 : 800: 3 ) as mobile phase. The flow rate was 1. 0 mL . min-1. The detection wavelength was 248 nm. Results:There is a good linear relationship within the range of 50 - 300 ug . mL-1 ( r = 0. 999 9 ) . The reproducibility and precision of the method is good(RSD <2% ). Conclusion .. The method proposed for determination of the content and related substances of sanazole by HPLC is simple and accurate. |
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| Keywords: | sanazole content determination related substances HPLC |
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