高效液相色谱-质谱法测定盐酸厄洛替尼中潜在致突变杂质0419  

A Convenient and User-friendly LC-MS/MS Analysis Method was Established for the Determination of Genotoxic Impuritiesin Erlotinib Hydrochloride

作　　者：孙琳 周君安 曹秀芝 魏娜 Sun Lin;Zhou Jun′an;Cao Xiuzhi;Wei Na(Jiangsu Hansoh Pharmaceutical Co.,Ltd.,Lianyungang 222000,China)

机构地区：[1]江苏豪森药业集团有限公司,江苏连云港222000

出　　处：《山东化工》2023年第1期138-139,146,共3页Shandong Chemical Industry

摘　　要：目的:建立盐酸厄洛替尼中潜在致突变杂质0419的测定方法。方法:采用高效液相色谱-质谱法,用十八烷基硅烷键合硅胶为填充剂(Agilent Poroshell 120 EC-C 18,4.6 mm×50 mm,2.7μm);以0.05%甲酸水溶液为流动相A,乙腈溶液为流动相B;柱温30℃;样品控温10℃;流速0.4 mL/min,进样体积10μL。结果:致突变杂质0419在0.61~121.58 ng/mL线性范围良好,定量限为0.61 ng/mL,检测限为0.12 ng/mL,回收率为92.6%,溶液稳定性良好。结论:该方法可以准确检测盐酸厄洛替尼中杂质0419的含量。Objective:A convenient and user-friendly LC-MS/MS analysis method was established for the determination of genotoxic impurities in erlotinib hydrochloride.Method:The following HPLC conditions are follows:separated on a C 18(Agilent Poroshell 120 EC-C 18,4.6 mm×50 mm,2.7μm)column maintained at 30℃,mobile phase A was 0.05 mol/L formic acid water solution,mobile phase B was ACN,gradient elution was used.The flow-rate was 0.4 mL/min and 10μL.Result:The assay was linear over the range 0.61~121.58 ng/mL with a limit of quantitiation of 0.61 ng/mL with a limit of detection of 0.12 ng/mL.The recovery rate of impurity was 92.6%and stabilities were good.Conclusion:The method can accurately determine the content of impurity 0419 in erlotinib hydrochloride.

关 键 词：盐酸厄洛替尼 高效液相色谱-质谱法 潜在致突变杂质 

分 类 号：O657.63[理学—分析化学]