摘要
目的:建立乙酰谷酰胺的含量测定方法,为该类药物提供质量控制标准。方法:采用Phenomenex C18色谱柱(250mm× 4．6mm,5μm),柱温35℃;以0．01mol·L-1醋酸铵溶液(用冰醋酸调节pH值至4．5)为流动相,流速为0．6ml·min-1,蒸发光散射检测器检测,漂移管温度为115℃,气体流量为3．2L·min1。结果:乙酰谷酰胺在0．198-0．991mg·mL-1范围内呈良好的线性关系,r=0．9993;平均回收率为98．9％,RSD=1．7％,n=6;最低检出量为50ng。结论:本方法简便、快速,结果准确、可靠、重现性好。
Objective ： To establish a method to determine the contents of acetylglutamide in its injections,and to evaluate the quality of this drug. Methods ：The column ： Phenomenex C18 column （250mm × 4.6mm, 5μm）, column temperature at 35℃;The mobile phase=0. 01mol ·L^-1 ammonium acetate solution （adjusted to pH4.5 with glacial acetic acid）with flow rate of 0. 6ml ·min^-1;The evaporative light-scatting detector（ELSD） ;the temperature of the drift tube was at 115℃ ,and the flow rate of gas at 3.2L ·min^-1. Results： The standard curve was linear within the range 0. 198～0.991mg· mL^-1,r=0. 9993;The average recovery was 98.9%（RSD = 1.7%, n = 6 ）. Conclusion： The method is simple and rapid. The results is accurate and reproducible.
出处
《中国药品标准》
CAS
2005年第6期21-23,共3页
Drug Standards of China
