| 枸橼酸坦度螺酮胶囊有关物质研究 |
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| 引用本文： | 何宇新,李玲,鲍文娟,陈功政,吴金伟.枸橼酸坦度螺酮胶囊有关物质研究[J].西华大学学报(自然科学版),2011,30(4):104-108. |
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| 作者姓名： | 何宇新 李玲 鲍文娟 陈功政 吴金伟 |
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| 作者单位： | 1. 西华大学生物工程学院,四川成都,610039
2. 四川科瑞德制药有限公司,四川成都,610041 |
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| 基金项目： | 西华大学天然药物研究与工程重点实验室项目(XZD0821-09-1) |
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| 摘 要： | 目的:建立枸橼酸坦度螺酮胶囊有关物质检查方法。方法:采用高效液相色谱法,以UltimateTM XB-C18(250 mm×4.6 mm,5μm)为色谱柱;流动相:0.01 mol/L磷酸二氢钾溶液体积∶乙腈体积(60∶40);检测波长:215 nm。结果:有效的分离了枸橼酸坦度螺酮胶囊中的有关物质,杂质A不得过0.3%,杂质B不得过0.4%,各杂质峰面积的和不大于对照溶液主峰面积的1.0。结论:此方法简便、快速,可用于枸橼酸坦度螺酮胶囊的质量控制。
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| 关 键 词： | 枸橼酸坦度螺酮 有关物质 质量标准 |
Study on Related Substances of Tandospirone Citrate Capsules |
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| HE Yu-xin,LI Lin,BAO Wen-juan,CHEN Gong-zheng,WU Jin-wei.Study on Related Substances of Tandospirone Citrate Capsules[J].Journal of Xihua University:Natural Science Edition,2011,30(4):104-108. |
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| Authors: | HE Yu-xin LI Lin BAO Wen-juan CHEN Gong-zheng WU Jin-wei |
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| Affiliation: | HE Yu-xin1,LI Lin1,BAO Wen-juan2,CHEN Gong-zheng2,WU Jin-wei1 (1.School of Bioengineering,Xihua University,Chengdu 610039 China,2.Chengdu keruide pharmaceutical co,.ltd,Chengdu 610041 China) |
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| Abstract: | HPLC was employed to determine the related compounds in tandospirone citrate capsules.The determination was performed on ultimateTM XB-C18(250mm×4.6mm,5μm)column,and the mobile phase was composed of methanol-solution of 0.01mol/L MKP-acetonitrile(60:40)and detection wavelength of 243nm.The related substances in tandospirone citrate capsules were separated effectively.The peak area of A foreign material was no more than 0.3% and the peak area of B foreign material was no more than 0.4%,and the total peak area of all foreign materials was no more than 1.0% of the main peak area of contrast solution.The method is simple and rapid,suitable for the quality control of tandospirone citrate capsules. |
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| Keywords: | Tandospirone Citrate related substance quality standard |
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