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目的采用离子色谱法测定丁二磺酸腺苷蛋氨酸原料药中丁二磺酸的含量。方法采用Dionex ICS 5000离子色谱仪,用IonpacAS14(250 mm×4 mm)阴离子交换色谱柱(分析柱),流动相为3.5 mmoL·L-1无水碳酸钠溶液-1.0 mmoL·L-1碳酸氢钠溶液,流速2.0 mL·min-1,电导检测器,进样量25μL。结果丁二磺酸0.037~558μg·mL-1与峰面积的线性关系良好(r=0.9996),平均回收率为99.9%,RSD=0.61%(n=9),检出限为0.3 ng。结论所用方法可准确测定丁二磺酸腺苷蛋氨酸中丁二磺酸的含量,可有效控制其质量。
OBJECTIVE To determine the content of butane sulfonic acid in adenosine methionine succinate by ion chromatography. Methods The Dionex ICS 5000 ion chromatograph was used with an anion exchange column (analytical column) of Ionpac AS14 (250 mm × 4 mm). The mobile phase was 3.5 mmoL·L -1 anhydrous sodium carbonate solution -1.0 mmoL·L -1 Sodium bicarbonate solution, flow rate 2.0 mL · min-1, conductivity detector, injection volume 25μL. Results The linear range of the peak area was 0.037 ~ 558μg · mL-1 for butylated sulfonic acid (r = 0.9996). The average recovery was 99.9% with RSD of 0.61% (n = 9). The detection limit was 0.3 ng. Conclusion The method can be used to determine the content of butane sulfonic acid in adenosine methionine succinate, which can effectively control its quality.