摘要
目的建立盐酸美金刚胶囊的溶出曲线测定方法。方法选用Lichrospher二醇基色谱柱(25cm×4mm,5μm),以0.34%磷酸氢二钾溶液-乙腈(60∶40)为流动相,流速0.8ml/min,检测波长为194nm。结果盐酸美金刚线性范围10.0~60.1μg/ml(r=0.9991),重复性试验RSD为1.9%,平均回收率99.3%。结论本方法测定简便,可用于该制剂的溶出曲线测定。
Objective To establish an HPLC Far-UV absorption spectra method for the determination of the dissolution curve of Memantine hydrochloride capsules.Methods Performed by a Lichrospher Diol column(25cm×4mm,5μm),and the mobile phase is consisted of 0.34% Potassium phosphate dibasic solution-acetonitrile(60:40) at a flow rate of 0.8ml/min.The detection wave was set at 194 nm.Results An excellent separation is achieved for Memantine hydrochloride.The assay is validated in the concentration range of 10.0~60.1μg/ml(r=0.9991) and the average recovery was 99.3%.Conclusions The method development is successfully used on the dissolution curve of Memantine hydrochloride capsules.
出处
《医药论坛杂志》
2011年第16期24-26,共3页
Journal of Medical Forum