离子色谱法测定合成多肽类药物中醋酸的含量

Content of acetic acid in synthetic polypeptide drugs determined by ion chromatography

目的：探索采用离子色谱法测定合成多肽药物中醋酸的含量。方法以DIONEX IonPac AS19（4 mm＆#215;250 mm）为色谱柱,淋洗液为3.2 mmol/L的碳酸钠和1.0 mmol/L碳酸氢钠混合溶液,流速为0.8 ml/min,抑制电流为70 mA,电导检测器进行检测。结果醋酸含量在14.2∽142.2μg/ml范围内线性相关系数为0.9997,回收率在98.1%∽100.7%,RSD为1.0%。结论离子色谱法简便快捷,结果准确,可替代高效液相色谱法用于测定合成多肽药物中醋酸的含量。

Objective To explore the content of acetic acid in synthetic polypeptide drugs determined by ion chro-matography. Methods Analytical column was DIONEX IonPac AS19 （4 mm＆#237;250 mm）,the leacheate was a solution of 3.2 mmol/L sodium carbonate mixed with 1.0 mmol/L sodium bicarbonate,flow velocity was 0.8 ml per minute,the curb was 70 mA,and electrical conductivity detector was applied for determination. Results The linearly dependent coeffi-cient was 0.9997 when the content of acetic acid ranged from 14.2 μg/ml to 142.2 μg/ml.The recovery rate was from 98.1% to 100.7% and percentage of relative standard deviation （RSD） was 1.0%. Conclusion Ion chromatography is simple,convenient and fast with accurate result,which can replace high performance liquid chromatography in determin-ing the content of acetic acid from synthetic polypeptide drugs.