建立了高效液相色谱法测定甲苯磺酸拉帕替尼的有关物质。采用Ultimate® XB-C18 色谱柱，以乙酸铵缓冲液( 取乙酸铵3.0 g，加水1 L 使溶解，用冰乙酸调至pH 4.0) ∶乙腈为流动相，梯度洗脱，检测波长260 nm。有关物质A、B、C与甲苯磺酸拉帕替尼分别在0.15 ～ 1.0、0.30 ～ 2.0、0.15 ～ 1.0 和0.50 ～ 10.0 μg/ml 范围内线性关系良好。有关物质A、B、C 的平均回收率分别为105.57％、103.47％和105.08％，RSD 分别为1.49％、5.85％和0.89％。有关物质A、B、C 与甲
苯磺酸拉帕替尼的检测限分别为0.05、0.05、0.10 和0.08 μg/ml。

An HPLC method was established for the determination of the related substances in lapatinib ditosylate. A C18 column was used, with the mobile phase of ammonium acetate buffer solution (dissolved 3.0 g of ammonium acetate in 1 L of water, adjusted to pH 4.0 by glacial acetic acid)∶acetonitrile by gradient elution at the detection wavelength of 260 nm. It was linear for the related substances A, B, C and lapatinib ditosylate in the concentration ranges of 0.15 - 1.0, 0.30 - 2.0, 0.15 - 1.0 and 0.50 - 10.0 μg/ml, respectively. Their average recoveries were 105.57％, 103.47％ and 105.08％, with RSDs of 1.49％, 5.85％ and 0.89％, respectively. The low limits of detection for the related substances A, B, C and lapatinib ditosylate were 0.05, 0.05, 0.10 and 0.08 μg/ml, respectively.