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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。
Objective: To establish a method for the determination of related substances in donepezil hydrochloride tablets by high performance liquid chromatography. METHODS: AlltimaTM C18 was used as the mobile phase with a mobile phase of 0.01 mol · L -1 potassium phosphate dibasic (3% triethylamine, pH = 4.3) -methanol (60:40) at a detection wavelength of 271 nm with a column temperature of 35 ℃, the flow rate of 1.0mL · min-1; the main component of the control method to calculate the relevant substance content. Results: The chromatographic conditions, the main components and related substances can be completely separated, the impurity peak separation well, the minimum detection limit of 0.05ng, the related substances were 0.42%. Conclusion: The method is specific, sensitive and reproducible, and can be used for the detection of related substances in this preparation.