Method for detecting aldehyde genotoxic impurities in high-purity varenicline tartrate raw material

The invention provides a method for detecting aldehyde genotoxic impurities in a high-purity varenicline tartrate raw material, which comprises the following steps: dissolving varenicline tartrate in water, adding an acetonitrile solution and a hydrochloric acid solution of 2, 4-dinitrophenylhydrazine, heating in a water bath at 60 DEG C for 2 hours, taking out, cooling to room temperature, filtering, and collecting the aldehyde genotoxic impurities in the varenicline tartrate. And taking the subsequent filtrate as a test solution, and determining by high performance liquid chromatography. The method is high in sensitivity, high in selectivity and simple and convenient to operate, the aldehyde genotoxic impurities in the high-purity varenicline tartrate raw material medicine can be quantitatively detected without tedious sample pretreatment, and the medicine safety is further guaranteed. 本发明提出的是一种高纯酒石酸伐尼克兰原料中醛类基因毒性杂质的检测方法，包括以下步骤：取酒石酸伐尼克兰加水溶解，加2,4-二硝基苯肼的乙腈溶液和盐酸溶液，置60℃水浴中加热2h后取出，冷却至室温过滤，取续滤液作为供试品溶液用高效液相色谱测定。该方法