HPLC法测定一种吡啶酮类医药中间体中5种杂质含量

Determination of five impurities in one kinds of pharmaceutical intermediate pyridinone by HPLC

目的建立1-(4-氨基苯基)-5,6-二氢-3-(4-吗啉基)-2(1H)-吡啶酮(以下简称SM1)中5种杂质的分析方法。方法采用HPLC方法,色谱柱:Waters SunFire C_(18)(150mm×4.6mm,3.5μm);流动相A:0.03mol·^(-1)乙酸铵缓冲液-甲醇(75∶25),流动相B:0.03mol·^(-1)乙酸铵缓冲液-甲醇(25∶75),线性梯度洗脱;柱温35℃;检测波长320nm。结果建立了SM1中5种杂质的分析方法,5种成分的线性关系良好,平均回收率为100.4%~104.5%。结论所建立的HPLC法专属性强、精密度好、准确度高,可以作为SM1中5种杂质的测定方法。

OBJECTIVE The method was established to determine five impurities in 1-(4-aminophenyl)-5,6-dihydro-3-(4-morpholinyl)-2(1H)-pyridinone(Hereinafter referred to as SM1).METHODS HPLC method was applied,the separation was performed on a Waters SunFire C_(18) column(150mm×4.6mm,3.5μm)by liner gradient elution using 0.03mol·L^(-1)ammonium acetate solution-methanol(75∶25)as mobile phase A,0.03mol·L^(-1)ammonium acetate solution-methanol(25∶75)as mobile phase B,the column temperature was set at 35℃,and the detected wavelength was set at 320nm.RESULTS The method was established to determine five impurities in SM1,which had good linear relationship,and the average recoveries were between 100.4%to 104.5%.CONCLUSION The established method has strong specificity,good precision and high accuracy,which can be used for simultaneous determination of impurities in SM1.