HPLC法检测盐酸多奈哌齐片中有关物质含量.pdfVIP

HPLC 法检测盐酸多奈哌齐片中有关物质含量 1，2＊ # 1 1 曹 嘉 ，冉 兰 ，陈 霞 （1. 四川大学华西药学院，成都市 610041；2. 四川抗菌素工业研究所，成都市 610052） 中图分类号 R927.2；R917 文献标识码 A 文章编号 1001- 0408（2010）13- 1239- 02 摘 要 目的：建立以高效液相色谱法检测盐酸多奈哌齐片中有关物质含量的方法。方法：色谱柱为AlltimaTM C18，流动相为0.01 mol ·L－1磷酸氢二钾溶液（含3％三乙胺，pH ＝4.3）- 甲醇（60∶40），检测波长为271nm ，柱温为35℃，流速为1.0mL ·min－1；以主成 分自身对照法计算有关物质含量。结果：该色谱条件下，主成分与有关物质能完全分离，各杂质峰分离良好，最低检测限为0.05 ng ，有关物质含量均为0.42％。结论：该方法专属性强、灵敏度高、重复性好，可用于该制剂中有关物质的检测。 关键词 盐酸多奈哌齐片；有关物质；高效液相色谱法 Determination of Related Substances in Donepezil Hydrochloride Tablets by HPLC CAO Jia ，RAN Lan ，CHEN Xia （West China School of Pharmacy ，Sichuan University ，Chengdu 610041，Chi- na ） CAO Jia（Sichuan Industrial Institute of Antibiotic Co. ，Ltd. ，Chengdu 610052，China ） ABSTRACT OBJECTIVE ：To establish an HPLC method for the determination of related substances in Donepezil hydrochloride tablets. METHODS ：The separation was performed on AlltimaTM C18 column with mobile phase consisted of 0.01mol ·L－1 dipotassi- um hydrogen phosphate （3％triethylamine ，pH ＝4.3）- methanol （60∶40）and flow rate of 1.0mL ·min－1. The detection wavelength was set at 271 nm and the column temperature was maintained at 35 ℃. The content of related substance was calculated by self- control with main component. RESULTS ：Related substances were completely separated from the main constituent and the im- purities were separated well from each other. The determination limit was 0.05 ng and the contents of related substances were 0.42％. CONCLUSION ：The method is specific ，sensitive and reproducible for the determination of related substances in Donepezil hydrochloride tablets. KEY WORDS Donepezil hydrochloride tablets ；Related substances ；HPLC 盐酸多奈哌齐（Donepezil hydrochloride ）的化学名为1- 苄 2.1 色谱条件与系统适用性试验 基- 4- [（5，6- 二甲氧基- 1- 茚满酮）- 2- 基）甲基]哌啶盐酸盐， 色谱柱：AlltimaTM C18（250mm×4.6mm ，5µm）；流动相： 是治疗阿尔