琥珀酸作为化学药品起始物料有关物质的研究

Study on Succinic Acid as Related Rubstance of Starting Material of Chemicals

目的对琥珀酸中的杂质进行研究,控制含量,保证药品质量。方法采用Dikma Diamonsil Plus C_(18)(4.6mm×250mm,5μm)色谱柱,以0.01mol/L磷酸盐缓冲液为流动相,流速1.0 ml·min^(-1)等度洗脱,检测波长为195nm,柱温25℃。结果琥珀酸在3.987~39.876μg·ml^(-1)范围内与峰面积呈良好的线性关系,其线性回归方程为A=669.27C+208.73(r=0.9992);加样回收率为99.403%;有关物质测定结果为0.04%。结论经方法学验证,该法可作为琥珀酸质量控制的方法。

Objective The impurities in succinic acid were studied to control the content and ensure the quality of medicine.Method A Dikma Diamonsil Plus C_(18)column(4.6 mm×250 mm,5μm)was used.The mobile phase was 0.01 mol/L phosphate buffer,the flow rate was 1.0 ml·min^(-1),the isometric elution was performed,the detection wavelength was 195 nm,the column temperature was 25℃.Result The linear regression equation of succinic acid was A=669.27C+208.73(r=0.9992)in the range of 3.987~39.876μg·ml^(-1),the recovery of the sample was 99.403%,and the determination results of related substances were 0.04%.Conclusion The method can be used for the quality control of succinic acid.