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.
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)
出处
《山东化工》
CAS
2023年第1期138-139,146,共3页
Shandong Chemical Industry
作者简介
孙琳,女,中级工程师,主要从事新药的质量研究及申报工作。
