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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 determine the contents of propafenone hydrochloride and its related substances in propafenone hydrochloride injection by HPLC method. METHODS: Cosmosil 5C8-MS column (250 mm × 4.6 mm, 5 μm) was used with 0.015 mol·L -1 potassium phosphate dibasic solution (adjusted to pH 2.5 with phosphoric acid) -acetonitrile (65:35) Mobile phase, flow rate 1.0 ml · min ~ (-1), detection wavelength 220 nm; column temperature: 30 ℃. RESULTS: Propafenone hydrochloride was completely separated from its adjacent impurity peaks. Propafenone had a good linearity (r = 0.9999) in the concentration range of 30 ~ 270μg · ml ~ (-1). Conclusion: The method is simple, accurate and specific. It can be used for the determination of propafenone hydrochloride injection and related substances.