离子色谱法测定那屈肝素钙注射液中游离硫酸盐含量

Content Determination of Free Sulfate in Nadroparin Calcium Injection by Ion Chromatography

目的建立测定那屈肝素钙注射液中游离硫酸盐含量的离子色谱法。方法色谱柱为IonPac^(TM) AS11-HC柱(250mm×4mm),保护柱为IonPac^(TM) AG11-HC柱(50mm×4mm),柱温为30℃;以3mmol/L碳酸钠溶液为淋洗液,流速为2.0mL/min;电导检测器,电导池温度为35℃;抑制电流为50mA。结果硫酸根离子质量浓度在1.0~20.0μg/mL范围内与峰面积线性关系良好,r=0.99995(n=5);精密度、稳定性、重复性试验的RSD均小于1.0%;平均加样回收率为98.40%,RSD为3.26%(n=6)。结论该方法操作简单,结果准确,灵敏度高,重复性好,可用于测定那屈肝素钙注射液中游离硫酸盐的含量。

Objective To establish an ion chromatography method for the content determination of free sulfate in Nadroparin Calcium Injection.Methods The chromatographic column was IonPacTMAS11-HC column(250 mm×4 mm)and the guard column was IonPacTMAG11-HC column(50 mm×4 mm),the column temperature was 30℃,3 mmol/L sodium carbonate solution was used as the isocratic eluent,the flow rate was 2.0 m L/min with a conductivity detector,the temperature of conductivity cell was 35℃,and the suppression current was 50 m A.Results The linear range of sulfate ion was 1.0-20.0μg/m L(r=0.99995,n=5),The RSDs of precision,stability and repeatability tests were less than 1.0%.The average recovery of sulfate ion was 98.40%with RSD of 3.26%(n=6).Conclusion The method is simple,accurate,sensitive and reproducible,which can be used for the content determination of free sulfate in Nadroparin Calcium Injection.