| HPLC测定硫普罗宁注射液含量及其有关物质 |
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| 引用本文： | 黄静,,尹燕杰,黄海伟,张启明,杭太俊. HPLC测定硫普罗宁注射液含量及其有关物质[J]. 中国药学杂志, 2009, 44(14): 1108-1111 |
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| 作者姓名： | 黄静 尹燕杰 黄海伟 张启明 杭太俊 |
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| 作者单位： | 1.中国药品生物制品检定所 北京 100050;2.中国药科大学药物分析教研室 南京 210009;3.河北省药品检验所 石家庄 050011;4.哈尔滨市食品药品检验检测中心 哈尔滨 |
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| 摘 要： | 目的建立了HPLC测定硫普罗宁注射液的含量及有关物质。方法采用Waters Symmetry C18柱(4.6mm×200mm,5μm);流动相:0.025mol·L-1磷酸二氢钾溶液(用磷酸调pH值至3.2)-乙腈(95∶5);检测波长:210nm;柱温:30℃;流速:1.0mL·min-1;进样量:20μL。结果硫普罗宁与杂质分离良好,在0.020～0.996g·L-1内呈良好的线性关系,r=0.9998。平均回收率(n=9)为99.50%。结论该方法灵敏快速、结果准确、重现性好,可用于该制剂的质量控制。
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| 关 键 词： | 硫普罗宁注射液 有关物质 高效液相色谱法 |
| 收稿时间： | 2009-03-25; |
Determination of Tiopronin Injection and Its Related Substances in Tiopronin Injection by HPLC |
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| HUANG Jing,,,YIN Yan-jie,HUANG Hai-wei,ZHANG Qi-ming,HANG Tai-jun. Determination of Tiopronin Injection and Its Related Substances in Tiopronin Injection by HPLC[J]. Chinese Pharmaceutical Journal, 2009, 44(14): 1108-1111 |
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| Authors: | HUANG Jing YIN Yan-jie HUANG Hai-wei ZHANG Qi-ming HANG Tai-jun |
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| Affiliation: | 1.National Institute for the Control of Pharmaceutical and Biological Products,Beijing 100050, China; 2. Pharmacy Experimental Center of China Pharmaceutical University,Nanjing 210009, China; 3.Hebei Institute for Drug Control, Shijiazhuang 050011, China; 4. Haerbin Experimental Center for Drug and Food, Haerbin 150525, China |
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| Abstract: | OBJECTIVE To establish a HPLC method for the determination of tiopronin injection and its related substances. METHODS The separation was performed on a Waters Symmetry C18 (4.6 mm×200 mm,5 μm) column. The mobile phase consisted of 0.1 mol·L-1 potassium dihydrogen phosphate solution(adjust to pH 3.2 with glacial acetic acid)-acetonitrile (95∶5). The detective wavelength was 210 nm. The column temperature was 30 ℃. The flow rate was 1.0 mL·min-1. The injection volume was 20 μL. RESULTS A good separation of tiopronin and main related substance was achieved. A good linearity was obtained over the range of 0.020～0.996 g·L-1 (r=0.999 8). The average recovery (n=9) was 99.50%. CONCLUSION The method is simple, quick, sensitive, accurate, repeatable and can be used to control the quality of tiopronin injection. |
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| Keywords: | tiopronin injection related substances HPLC |
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