HPLC法检查盐酸多奈哌齐制剂中的有关物质

Determination of Related Substances in Donepezil Hydrochloride Preparations by HPLC

目的：建立适用于多种盐酸多奈哌齐制剂有关物质检查的方法，为该品种国家标准的统一提供依据。方法：采用高效液相色谱法。色谱柱为Thermo Hypersil GOLD C18流动相为含有1-癸烷磺酸钠、乙腈、高氯酸的混合水溶液，流速为1．0ml／min，检测波长为271nm，柱温为35℃，进样量为20μl。采用自身对照法检查盐酸多奈哌齐片、胶囊和分散片3种制剂共9批样品中的有关物质。结果：盐酸多奈哌齐的检测质量浓度线性范围为0．22～13．40μg／ml（r=0.9999），相应的杂质限度范围为0．05％～3．0％，系统精密度试验、稳定性试验的RSD≤0．5％；9批样品中总杂质量≤0．44％（n=2）。结论：建立的方法准确、简便，可用于盐酸多奈哌齐大部分口服制剂的有关物质检查，可为完善和统一现行众多的国家标准提供支持。

OBJECTIVE： To establish the method for the determination of related substances in Donepezil hydrochloride preparations. METHODS： HPLC method was adopted. The determination was performed on Thermo Hypersil GOLD C18 with mobile phase consisted of sodium 1-decansulfonate-acetonitrile-perchloric acid at the flow rate of 1.0 ml/min. The detection wavelength was set at 271 nm and column temperature was 35 ℃. The injection volume was 20 μl. Related substance of 9 batches of Donepezil hydrochloride tablets, capsules and dispersible tablets were determined by self-control method. RESULTS ： The linear range of donepezil hydrochloride was 0.22-13.40 μg/ml （r=0.999 9） and the limit of related impurity was 0.05%-3.0%. RSD of precision and stability tests were ≤0.5% ; total content of impurity were ≤0.44% （n=2） in 9 batches of samples. CONCLUSIONS： The method is accurate and simple, and can be used for the determination of related substance in most of Donepezil hydrochloride oral preparation, and provid support for the pcrfection and unite on the current, numerous national standards.