反相高效液相色谱法测定利斯的明胶囊的溶出度  

Determination of dissolution of rivastigmine by reverse-phase high performance liquid chromatography

作　　者：黄滔敏[1,2] 陈念祖 段更利[2] 

机构地区：[1]复旦大学附属眼耳鼻喉科医院药剂科,上海200031 [2]复旦大学药学院

出　　处：《中国新药与临床杂志》2007年第2期123-125,共3页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的:建立测定利斯的明溶出度的反相高效液相色谱(RP-HPLC)法。方法:采用Agilent 1100型高效液相色谱仪,DiamonsilTM C18柱(150 mm×4．0 mm,5μm),以0．025 mol·L-1磷酸二氢钾／0．1％三乙胺(pH=6．7):乙腈=72:28(V／V)为流动相,流速1．0 mL·min-1,检测波长263 nm。结果:利斯的明在3．604～530 mg·L-1范围内呈良好的线性关系(r=0．999 9,n=5),平均回收率在99％～101％之间,精密度尺RSD<5％,样品稳定性好。45 min三批胶囊溶出度均在70％以上,符合规定。结论:本方法结果准确,重复性好,方法简便可行。AIM： To establish a reversed-phase HPLC method for the determination of dissolution of rivastigmine. METHODS： Chromatographic analyses were performed on an Agilent 1100 LC system and a Diamonsil C18 analytical column （150 × 4.0 mm, i.d. 5 μm） . The mobile phase consisted of 0.025 mol·L^-1 KH2PO4/ 0.1% triethylamine （pH = 6.7） ： acetonitrile （72 ： 28, V/V） and flow rate was 1.0 mL·min^-1. The detection wavelength was 263 nm. RESULTS： Rivastignmine showed good linear relationship within the range of 3.604 - 530 mg.L^-1 （r = 0.999 9, n = 5） with average recoveries of 99 % - 101% and RSD of intra- and inter-day assays lower than 5 %, and still more possessing good stability. The dissolutions of three batches of capsules at 45 min were greater than 75 % coinciding with the qualification. CONCLUSION： The reversed-phase HPLC method for the determination of rivastigmine is accurate, simple, and reproducible.

关 键 词：色谱法 高压液相 利斯的明 胆碱脂酶抑制剂 溶出度 

分 类 号：R927.11[医药卫生—药学] R971.91