A novel, simple and stability indicating reverse-phase high performance liquid chromatographic method with UV detection at 220 nm (RP-HPLC-UV) was established to realize the simultaneous analysis of carbetocin and ten related impurities. This paper performed the most comprehensive impurity profiling of carbetocin, including the synthesis-related impurities, the isomers of carbetocin and the degradants formed from the forced degradation research, the structures of which were tentatively identified by a two-dimensional liquid chromatography-mass spectrometry technology. The novelty of this RP-HPLC-UV method was demonstrated by its satisfactory resolution and selectivity, which was achieved using an YMC-pack C18 column kept at 40 ℃, and optimal organic modifier gradient. The mobile phase A was potassium dihydrogen phosphate buffer (pH 6.5)—acetonitrile (80:20, v/v), and the mobile phase B was potassium dihydrogen phosphate buffer (pH 6.5)—acetonitrile (72:28, v/v). The forced degradation research proved the stability-indicating capacity of the method and validation study was performed according to ICH requirements. In summary, this RP-HPLC-UV method could support the simultaneous determination of related substances of carbetocin in bulk drug and in pharmaceutical formulations.

为了实现卡贝缩宫素和10种相关杂质的同时分析，建立了一种新颖、简单、稳定的指示反相高效液相色谱220 nm紫外检测法(RP-HPLC-UV)。本文对卡贝缩宫素进行了最全面的杂质分析，包括合成相关杂质、卡贝缩宫素的异构体和强制降解研究中形成的降解物，其结构通过二维液相色谱-质谱技术初步鉴定. 这种 RP-HPLC-UV 方法的新颖性体现在其令人满意的分离度和选择性，这是使用保持在 40 ℃ 的 YMC-pack C18 色谱柱和最佳有机改性剂梯度实现的。流动相 A 为磷酸二氢钾缓冲液（pH 6. 5)-乙腈(80:20, v/v)，流动相B为磷酸二氢钾缓冲液(pH 6.5)-乙腈(72:28, v/v)。强制降解研究证明了该方法的稳定性指示能力，并根据 ICH 要求进行了验证研究。总之，该 RP-HPLC-UV 方法可以支持同时测定原料药和药物制剂中卡贝缩宫素的有关物质。