GC法测定福辛普利钠中异丁醛残留

Determination of Isobutyraldehyde Residues in Fosinopril Sodium by GC Method

采用GC法测定福辛普利钠原料药中异丁醛(含有致癌警示官能团)的残留量。采用DB-624(0.53 mm×30 m,3μm)色谱柱;流速为2.0 m L/min;起始温度50℃,保持10 min后,以10℃/min的速度升至180℃,保持2 min,顶空进样;FID检测器。异丁醛的线性范围为0.75~4.2μg/m L,相关系数为0.9995;精密度良好,RSD小于10%;准确度高,平均回收率为92.9%,在90%~110%之间。本法专属性强,准确度高,灵敏度高,精密度良好,耐用性强,适合于福辛普利钠原料药中异丁醛的残留量的测定。

The quantitative determination of isobutyraldehyde（potential genotoxic） in Fosinopril sodium by GC method was established. The analytical column was GC DB-624（0. 53 mm × 30 m,3 μm） column. The column temperature was maintained at 50 ℃ for 10 min,then increased to 180 ℃ at 10 ℃/min and maintained at 180 ℃ for2 min with headspace injection. The detector was FID. The linear range of isobutyraldehyde was 0. 75 ~ 4. 2 μg/m L,the correlation coefficient was 0. 9995,and precision RSD was less than 10%. The average recovery of isobutyraldehyde was92. 9% in the range of 90% ~ 110%. This method was rapid, accurate and reliable for the determination of isobutyraldehyde content in Fosinopril sodium.