建立了高效液相色谱法测定富马酸卢帕他定片的有关物质。采用Phenomenex Gemini NX-C18色谱柱,以20 mmol/L磷酸二氢钠溶液(含0.1%三乙胺,用磷酸调至pH 5.5)为流动相A,乙腈为流动相B,线性梯度洗脱,检测波长210 nm。结果显示卢帕他定与相邻杂质及各杂质之间的分离度均大于1.5;季铵盐杂质2、脱吡啶杂质3、二聚杂质4和N-氧化物杂质5的定量限分别为34、21、102和38 ng/ml,且在相应范围内线性关系良好;上述有关物质的相对校正因子分别为1.4、0.9、1.1和1.2,平均回收率分别为102.3%、100.8%、98.7%和99.5%,RSD分别为1.9%、1.7%、3.9%和2.2%。经验证,本法专属性、精密度、准确度和耐用性良好,可用于富马酸卢帕他定片有关物质的测定。 A HPLC method was established for the determination of rupatadine fumarate tablets. The mobile phase A was a Phenomenex Gemini NX-C18 column with 20 mmol / L sodium dihydrogen phosphate solution (containing 0.1% triethylamine and adjusted to pH 5.5 with phosphoric acid). Acetonitrile was used as mobile phase B, Detection wavelength of 210 nm. The results showed that the separation between rupatadine and adjacent impurities and impurities was more than 1.5. The quantitative limits of quaternary ammonium salt 2, decopyridine impurity 3, dimerization impurity 4 and N-oxide impurity 5 were 34 , 21,102 and 38 ng / ml, respectively, and had good linearity in the corresponding range. The relative correction factors of the above substances were 1.4, 0.9, 1.1 and 1.2, respectively. The average recoveries were 102.3%, 100.8% and 98.7% 99.5% with RSDs of 1.9%, 1.7%, 3.9% and 2.2% respectively. Proven, the law of specificity, precision, accuracy and durability is good, can be used for determination of rupatadine fumarate tablets related substances.