乙酰谷酰胺铝颗粒的制备与质量控制

Preparation of aceglutamide aluminum granulesand its quality control

目的：制备乙酰谷酰胺铝颗粒剂，并建立其质量控制标准。方法：以蔗糖为矫味剂制备乙酰谷酰胺铝颗粒剂，采用高效液相色谱法（HPLC）测定该颗粒剂中乙酰谷酰胺铝的含量与有关物质，并进行了稳定性试验。结果：HPLC线性关系起好，乙酰谷酰胺铝的线性范围为2．5～100mg·L^-1（r=0．9999），平均回收率为100．1％，RSD为0．45％（n=9）。结论：该颗粒剂处方合理，工艺简单，质量控制方法准确可靠，专属性好。

OBJECTIVE To prepare aceglutamide aluminum granules and establish a standard for its quality control. METHODS Aceglutamide aluminum granules were prepared by using sucrose as a sweet excipient,aceglutamide aluminum and its related substances in granules was determinated by high performance liquid chromatography（HPLC）, and its stability test was also carried out. RESULTS A good linearity of calibration curve for the HPLC method was obtained, and the calibration curve of aceglutamide aluminum was linear in the concentration range of 2.5～100mg·L^-1（r = 0. 999 9）, the average recovery was 100. 1% and RSD was 0. 45% （n = 9）. CONCLUSION The recipe of aeeglutamide aluminum granules is suitable and the preparation is simple. The method of quality control is accurate, reliable and specific.