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| HPLC法测定盐酸普罗帕酮注射液的含量及有关物质 | |
| 引用本文： | 金晓东,艾华,林惠.HPLC法测定盐酸普罗帕酮注射液的含量及有关物质[J].中国药师,2010,13(1):89-91. |
| 作者姓名： | 金晓东 艾华 林惠 |
| 作者单位： | 1. 解放军161医院药械科,武汉,430010 2. 湖北航天医院药剂科 3. 武汉市东西湖区妇幼保健院 |
| 摘 要： | 目的：用HPLC法测定盐酸普罗帕酮注射液中盐酸普罗帕酮的含量及其有关物质。方法：采Cosmosil 5C8-MS色谱柱 （250mm×4．6mm，5μm），以0．015mol·L^-1磷酸氢二钾溶液（用磷酸调节pH为2．5）-乙腈（65：35）为流动相，流速1．0ml·min^-1，检测波长为220nm；柱温：30℃。结果：盐酸普罗帕酮与其相邻杂质峰能完全分离，盐酸普罗帕酮在30～270μg·ml^-1浓度范围内线性关系良好（r=0．9999）。结论：该方法简便、准确、专属性好，可以用于盐酸普罗帕酮注射液的含量测定及有关物质检查。 |
| 关 键 词： | 盐酸普罗帕酮 含量测定 有关物质 高效液相色谱法 |
Determination of Propafenone Hydrochloride Injection and its Related Substances by HPLC |
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| Jin Xiaodong,Ai Hua,Lin Hui.Determination of Propafenone Hydrochloride Injection and its Related Substances by HPLC[J].China Pharmacist,2010,13(1):89-91. | |
| Authors: | Jin Xiaodong Ai Hua Lin Hui |
| Institution: | 1. Department of Pharmacy, No. 161 Hospital of PLA, Wuhan 430010, China ;2. Department of Pharmacy,Hubei Space Hospital;3. Dongxihu District Maternal and Child Health Hospital,Wuhan) |
| Abstract: | Objective： To establish an HPLC method for the determination of propafenone hydrochloride injection and its related substances. Method： The Cosmosil 5C8-MS column （250mm×4.6mm,5μm）was used as analytical column,the mobile phase consisted of 0.015 mol.L^-1 potassium dihydrogen phosphate aqueous solution （adjusted pH to 3.5 by phosphoric acid）-acetonitrile （65： 35） ,flow rate was 1.0 ml.min^-1. The ultraviolet detection wavelength was at 220 nm, and column temperature was 30 ℃. Result： Propafenone hydrochloride could be completely separated from the other impurities. The linear range of the propafenone hydrochloride was 30-270 μg.ml^-1 （ r = 0.999 9 ）. Conclusion： The method is simple, accurate and suitable for assaying the propafenone hydroehloride injection and its related substance. |
| Keywords: | Propafenone hydroehloride Determination Related substances HPLC |
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