盐酸多奈哌齐胶囊溶出度测定方法的研究

Determination of dissolution of donepezil hydrochloride capsules

目的：建立了RP-HPLC法测定盐酸多奈哌齐胶囊的溶出度.方法：采用Thermo Hypersil GOLD C18（150mm ×4.6 mm,5μm）色谱柱;以乙腈-水-高氯酸（350：650：1）为流动相;检测波长：271 nm;流速：1.0 ml/min;柱温：40℃.结果：盐酸多奈哌齐在1.216～ 10.944 μg/ml的浓度范围内与其峰面积呈良好线性关系（r=0.999 9）;平均回收率为99.6％,RSD为1.3％（n=9）.结论：该方法简便、准确、重现性好,能有效控制药品质量.

Objective： To establish an HPLC method for determination of dissolution of Donepezil Hydrochloride Capsules. Methods ： A Thermo Hypersil GOLD C18 （ 150 mm ×4.6 mm,5μm） column was used.with a mobile phase consisting of a mixture of acetonitrile -water -perchloric acid（350： 650： 1 ）. The detection wavelength was 271 nm and the flow rate of the mobile phase was 1.0 mL/min. Column temperature was set at 40 ℃. Results：The liner range of donepezil hydrochloride was 1. 216 -10. 944 μg/ml （r = 0. 999 9 ）. The average recovery of donepezil hydrochloride from the capsules was 99.6% （ n = 9 ） with RSD 1.3 %. Conclusion： The method is simple, accurate and sensitive, and it can be used as a method of quality control.