盐酸美金刚胶囊的丹磺酰氯柱前衍生化-HPLC法测定

Determination of Memantine Hydrochloride Capsules by HPLC with Dansylation

建立了柱前衍生化-HPLC法测定盐酸美金刚胶囊的含量。样品与丹磺酰氯在25℃、避光衍生化反应90 min后测定。采用C_8色谱柱,以磷酸盐缓冲液(pH 3.0)-乙腈(25:75)为流动相,检测波长218 nm。在5～180μg/ml浓度范围内线性关系良好(r=0.999 9),日内和日间RSD为1.15%和0.48%,平均回收率为99.7%～101.1%,衍生化产物在17 h内稳定。

An HPLC method with pre-column derivatization was established for determination of memantine hydrochloride capsules. The derivatization reaction was carried out with dansyl chloride under lightproof condition for 90 min at 25 ℃. A C8 column was used, with mobile phase of phosphate buffer （pH 3.0） - acetonitrile （25 ： 75）, at the detection wavelength of 218 nm. The calibration curve was linear in the concentration range of 5 - 180 μg/ml （r = 0.999 9）. The RSDs of intra- and inter-day were 1.15 % and 0.48%. The average recoveries were 99.7 % - 101.1%. The derivative was stable within 17 h.