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| HPLC法测定佐米曲普坦的含量及有关物质 | |
| 引用本文： | 阎平,冯翠玲,谢剑炜. HPLC法测定佐米曲普坦的含量及有关物质[J]. 中国药物应用与监测, 2004, 1(2): 30-32 |
| 作者姓名： | 阎平 冯翠玲 谢剑炜 |
| 作者单位： | 军事医学科学院毒物药物研究所,北京,100850 |
| 摘 要： | 目的:建立HPLC法测定佐米曲普坦的含量及纯度.方法:采用Zorbax SB-C18色谱柱,分别以甲醇:0.025mol/L磷酸二氢钾(16:84)和甲醇:0.025 mol/L磷酸二氢钾:三乙胺(25:75:0.5,pH=3.5)为流动相,流速为1mL/min,在检测波长为220nm处检测.结果:本品在0.01mg/mL～0.15mg/mL浓度范围内呈直线关系,本品中杂质的最小检测限为0.01%.对4批样品进行检测均未检出杂质,而粗品检出明显杂质.结论:本方法可用于含量测定和有关物质的检查. |
| 关 键 词： | 高效液相色谱法 佐米曲普坦 含量 有关物质 |
| 文章编号： | 1672-8157(2004)02-0030-03 |
| 修稿时间： | 2004-04-30 |
Methodology for determination of zolmitriptan content and its impurities by HPLC |
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| YAN Ping,FENG Cui - ling,XIE Jian - wei. Methodology for determination of zolmitriptan content and its impurities by HPLC[J]. , 2004, 1(2): 30-32 | |
| Authors: | YAN Ping FENG Cui - ling XIE Jian - wei |
| Abstract: | Objective: To develop high pressure liquid chromatography (HPLC) in order to detect the content and purity of zolmitriptan. Methods: Using ODS - C18 column,methanol;0. 025 mol/L KH2PO4 (16: 84)and methanol:0.025 mol/L KH2PO4:triethylamine(25:75:0. 5, pH = 3. 5) as mg/mL mobile phase, at a flow rate of 1mL/min, wavelength of detector was 220nm. Results: There is a good linear relationship within the range of 0.01mg/mL - 0. 15mg/mL( r = 0. 9999) .It was found that the minimum detective limits of the impurities were 0.01%.Four batches of zolmitriptan synthesized by our institute were analyzed and no impurities were found, but obvious impurities were delected in crude product samples. Conclusion: The method established in our experiment can be used to detect the zolmitriptan drug content and the impurities. |
| Keywords: | HPLC Zolmitriptan Content Related substances |
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