离子色谱法测定富马酸比索洛尔原料中的异丙胺

Determination of Isopropylamine in Bisoprolol Fumarate by Ion Chromatography

目的:采用离子色谱法测定富马酸比索洛尔原料中的异丙胺。方法:采用IonPac^(®)CS17型阳离子色谱柱(250 mm×4 mm),以5 mmol·L^(-1)甲基磺酸溶液为淋洗液A,60 mmol·L^(-1)甲烷磺酸溶液为淋洗液B,梯度洗脱,流速为1.0 ml·min^(-1),采用抑制电导检测器进行测定。结果:异丙胺浓度在0.099~123.750μg·ml^(-1)(r=0.999 8)内线性关系良好。平均回收率为99.64%(RSD=0.66%,n=9)。不同国产原料中异丙胺的含量约为0.001%。结论:该方法准确、简便、快速,适用于富马酸比索洛尔原料中异丙胺的测定。

Objective: To establish an ion chromatography method for the determination of isopropylamine in bisoprolol fumarate. Methods: An IonPac^(®)CS17(250 mm×4 mm) column was adopted. The mobile phase A consisted of 5 mmol·L^(-1)methanesulfonic acid, and the mobile phase B consisted of 60 mmol·L^(-1)methanesulfonic acid with gradient elution. The flow rate was 1.0 ml·min^(-1).The detection was performed in a conductivity detection mode. Results: The linear correlation coefficient of isopropylamine was 0.999 8 within the range of 0.099-123.750 μg·ml^(-1). The mean recovery of isopropylamine was 99.64%(RSD=0.66%,n=9). The contents of isopropylamine in bisoprolol fumarate from different enterprises were about 0.001%. Conclusion: The method is accurate, simple and quick for the determination of isopropylamine in bisoprolol fumarate.