HPLC法检测盐酸多奈哌齐片中有关物质含量

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0.01mo·lL-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0.05ng,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。

Determination of Related Substances in Donepezil Hydrochloride Tablets by HPLC

OBJECTIVE： To establish an HPLC method for the determination of related substances in Donepezil hydrochloride tablets. METHODS： The separation was performed on Alltima^TM C18 column with mobile phase consisted of 0.01 mol·L^-1 dipotassium hydrogen phosphate （3% triethylamine, pH=4.3）-methanol（60：40） and flow rate of 1.0 mL·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 impurities 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.