RP-HPLC法测定注射用乙酰谷酰胺的含量

Determination of the content of acetylglutamide for injection by RP-HPLC

目的建立测定注射用乙酰谷酰胺含量的反相高效液相色谱法.方法采用Alltech C18色谱柱(250 mm×4.6 mm,5 μm),pH 5.8磷酸盐缓冲液-甲醇(90:10)为流动相,流速为0.8 mL·min-1,检测波长为220 nm.结果乙酰谷酰胺在0.033 25～1.064 mg·mL-1峰面积与其测定浓度呈良好的线性关系(r=0.999 8),平均回收率为99.97%,重复性试验RSD为0.51%(n=6).结论本法准确、简便、快速,适用于注射用乙酰谷酰胺的质量控制.

OBJECTIVE To establish an RP-HPLC method to determine acetylglutamide.METHODS The separation was performed on an Alltech C_ 18 column(250 mm×4.6 mm,5 μm).The mobile phase was composed of phosphate buffer(pH 5.8)-methanol(90∶10)with the flowing rate of 0.8 mL·min -1,and the detective wavelength was at 220 nm.RESULTS There was a good linearity within 0.033 25～1.064 mg·mL -1 of acetylglutamide(r=0.999 8).The average recovery was 99.97%,and the RSD was 0.51%(n=6).CONCLUSIONS The method is accurate,simple and rapid.It is suitable for the quality control of acetylglutamide for injection.