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| 雷诺嗪有关物质及其含量的HPLC快速测定 | |
| 引用本文： | 傅收,于斐,王华栋,吴拥军. 雷诺嗪有关物质及其含量的HPLC快速测定[J]. 中国当代医药, 2009, 16(6): 12-13 |
| 作者姓名： | 傅收 于斐 王华栋 吴拥军 |
| 作者单位： | 1. 河南省天方药业股份有限公司,河南驻马店,463000 2. 郑州大学公共卫生学院,河南郑州,450001 3. 河南省医疗器械检验所,河南郑州,450003 |
| 摘 要： | 目的：建立雷诺嗪有关物质及其含量的HPLC测定方法。方法：以YMC—Pack ODS—A C18（4．6mm×150．0mm，5μm）为色谱柱；流动相为0．05mol／L磷酸二氢钾缓冲溶液（含0．2％的三乙胺）-乙腈（48：52）；流速为1．0ml／min；进样量为10μl；检测波长为215nm。结果：在0．06-150．00μg／ml浓度范围内呈良好的线性关系，相关系数r=0．9999，日内精密度RSD为0．61％，日间精密度RSD为1．40％（n=6）；平均回收率为100．5％，RSD为1．3％（n=9）。结论：本文所建立的方法，简便、重现性好、准确度高，可适用于雷诺嗪及其有关物质的含量测定。 |
| 关 键 词： | 雷诺嗪 高效液相色谱法 含量测定 有关物质 |
Determination of Ranolzaine and Related Substances by HPLC |
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| FU Shou,YU Fei,WANG Huadong,WU Yongjun. Determination of Ranolzaine and Related Substances by HPLC[J]. http://www.botanicus.org/, 2009, 16(6): 12-13 | |
| Authors: | FU Shou YU Fei WANG Huadong WU Yongjun |
| Affiliation: | FU Shou, YU Fei, WANG Huadong, WU Yongjun. (1.Henan Topfond Pharmaceutical Co., Ltd., Zhumadian 463000, China;2.College of Public Health, Zhengzhou University, Zhengzhou 450001, China; 3.Medical Instrument Testing Institute of Henan Province, Zhengzhou 450003, China) |
| Abstract: | Objective： To establish a HPLC method for detection of the ranolzaine and related substances. Methods： YMC - Pack ODS-A C18 （4.6 mm×150.0 mm,5μm） as analytical column; 0.05 mol/L KH2PO4 （0.2% triethylamine）-acetoni trile（48：52）as mobile phase with UV detection at 215 nm, the flow rate was 1.0 ml/min, 10 μl sample was injected in column. Results： The method was linear in the 0.06-150.00 μg/ml concentration range （r=-0.999 9）. Within-day precision and day to day precision were 0.61% and 1.40% （n=6） respectively. Average recovery was 100.5%（RSD=1.3%）. Conclusion： This method is accurate, simple and sensitive, and it can be used for the assay of ranolzaine and its related substances. |
| Keywords: | Ranolzaine HPLC Determination Related substances |
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