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(250 mm×4.6 mm,5μm),以0.015 mol·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1.0 ml·min^(-1),检测波长为220 nm;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。
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.
出处
《中国药师》
CAS
2010年第1期89-91,共3页
China Pharmacist
