浩瀚色谱（山东）应用技术开发有限公司建立气相色谱法测定美金刚(盐酸美金胺)的溶出度和含量的方法。方法药品碱化后用正己烷萃取。采用玻璃气相色谱柱,柱温为程序升温,氢火焰离子化检测器(FID),分流比5:1。用萘作内标,以内标法峰面积定量。结果盐酸美金刚在10-120mg·L-1内进样量与峰面积呈线性关系,平均回收率为99.4%,RSD为1.05%(n=12)。结论本方法简便、准确、重现性好,可作为本制剂的质量控制方法。

　　名称:硬质玻璃柱

　　固定相:2%阿皮松L和1%氢氧化钾的

　　高效白色硅藻土（100-120目 ）

　　规格:2m*1/4

　　编号:20240328002

　　温度:250°C

　　适用于:安捷伦7890B，7820A，8860,8890，6890

　　Haohan Chromatography (Shandong) Application Technology Development Co., Ltd. has established a gas chromatography method to determine the dissolution and content of Memantine hydrochloride. Method: After the drug is alkalized, it is extracted with n-hexane. Using a glass gas chromatography column with programmed heating, a hydrogen flame ionization detector (FID), and a split ratio of 5:1. Use naphthalene as the internal standard and quantify the peak area using the internal standard method. The results showed a linear relationship between the injection amount and peak area of Memantine Hydrochloride in the range of 10-120mg · L-1, with an average recovery rate of 99.4% and an RSD of 1.05% (n=12). Conclusion: This method is simple, accurate, and has good reproducibility, and can be used as a quality control method for this preparation.

　　Name: Hard glass column

　　Fixed phase: 2% apisone L and 1% potassium hydroxide

　　Efficient white diatomaceous earth (100-120 mesh)

　　Specification: 2m * 1/4

　　Number: 20240328002

　　Temperature: 250 ° C

　　Applicable to: Agilent 7890B, 7820A, 886088906890