| 高效液相色谱法测定复方罗红霉素片的有关物质 |
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| 引用本文： | 魏珺,陈国俊. 高效液相色谱法测定复方罗红霉素片的有关物质[J]. 中国药业, 2009, 18(5): 28-29 |
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| 作者姓名： | 魏珺 陈国俊 |
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| 作者单位： | 扬子江药业集团有限公司,江苏,泰州,2253211 |
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| 摘 要： | 目的建立测定复方罗红霉素片有关物质的高效液相色谱法。方法采用Diamonsil ODS C18柱（250mm×4．6mm，5μm），以0．067mol／L磷酸二氢铵溶液（用三乙胺调pH至6．5）-乙腈（65：35）为流动相，检测波长210nm，流速1．5mL／min，室温操作，采用不加矫正因子的主成分自身对照法。结果有关物质与主药的分离效果较好（R〉1．5）。结论方法重现性好、操作简单，可用于药品的质量控制。
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| 关 键 词： | 复方罗红霉素片 有关物质 高效液相色谱法 |
Determination of Related Substances of Compound Roxithromycin Tablets by HPLC |
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| Wei Jun,Chen Guojun. Determination of Related Substances of Compound Roxithromycin Tablets by HPLC[J]. China Pharmaceuticals, 2009, 18(5): 28-29 |
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| Authors: | Wei Jun Chen Guojun |
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| Affiliation: | ( Yangtze River Pharmaceutical Group Co., Ltd., Taizbou, Jiangsu, China 225321) |
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| Abstract: | Objective To establish a HPLC method for the determination of the related substances in Compound Roxithromycin Tablets. Methods The separation was accomplished on the Diamonsil ODS C18 column（250 mm ×4. 6 mm, 5 μm）, the mobile phase consisted of 0.067 mol/L ammonium dihydrogen phosphate solution（adjusting to pH 6.5 with triethylamine）-acetonitrile （65：35） .The detection wavelength was 210hm. The flow rate was 1.5 mL/min. Results The related substances and the main drug could be separated well（R〉 1.5）. Conclusion The present study provides a simple, reproducible method for the quality evaluation and controlof Compound Roxithromycin Tablets. |
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| Keywords: | Compound Roxithromycin Tablets related substance HPLC |
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