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 C18 4.6 mm× 150 mm,3.5 μm),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20 pL.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0.01～4.0 μg/mL质量浓度范围内线性关系良好,在0.2～3.0 μg/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.
Abstract
A HPLC method has been established for detecting six impurities in Benzylamine.A octadecylsilane bonded silica gel liquid chromatography column(Waters XBridge C18 4.6 mm×150 mm,3.5 pm)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 20 μL.The results indicate that this method has strong specificity,precision,durability,and high sensitivity.The linear relationship is good within the range of 0.01～4.0 pg/mL,and the recovery rates of the three concentration levels within the range of 0.2～3.0 pg/mL are within the range of 94.3％～107.6％.The accuracy is good and can be used for the quality control of Benzylamine.
维普
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