高效液相色谱法测定苄胺中6个杂质含量的方法学研究  

HPLC Analysis and Methodology Study on the Determination of Six Impurities in Benzylamine

作　　者：韦锦宁 黎炎 邱新莲 叶煌杰 罗恒真 WEI Jinning;LI Yan;QIU Xinlian;YE Huangjie;LUO Hengzhen(Jiangxi Kerui Pharmaceutical Co.,Ltd.,Ganzhou 341000,China)

机构地区：[1]江西科睿药业有限公司,江西赣州341000

出　　处：《山东化工》2024年第21期178-182,共5页Shandong Chemical Industry

摘　　要：建立测定苄胺中6个杂质含量的高效液相色谱方法,该方法使用十八烷基硅烷键合硅胶液相色谱柱(Waters XBridge C_(18)4.6 mm×150 mm,3.5μm),10 mmol/L碳酸氢铵溶液和乙腈为流动相,梯度洗脱,流速为1 mL/min,检测波长为210 nm,柱温为30℃,进样体积20μL。结果表明,本方法专属性强,精密度、耐用性等良好,灵敏度高,在0.01~4.0μg/mL质量浓度范围内线性关系良好,在0.2~3.0μg/mL质量浓度范围内三个浓度水平回收率在94.3%~107.6%范围内,准确度良好,可用于苄胺的质量控制。A HPLC method has been established for detecting six impurities in Benzylamine.A octadecylsilane bonded silica gel liquid chromatography column(Waters XBridge C_(18)4.6 mm×150 mm,3.5μm)was used,10 mmol/L ammonium bicarbonate solution and acetonitrile as mobile phase,and gradient elution.The flow rate is 1 mL per minute.The detection wavelength is 210 nm,the column temperature is 30℃,and the injection volume is 20μL.The results indicate that this method has strong specificity,precision,durability,and high sensitivity.The linear relationship is good within the range of 0.01~4.0μg/mL,and the recovery rates of the three concentration levels within the range of 0.2~3.0μg/mL are within the range of 94.3%~107.6%.The accuracy is good and can be used for the quality control of Benzylamine.

关 键 词：高效液相色谱法 苄胺 杂质 方法学 

分 类 号：O657.7[理学—分析化学]