HPLC法测定盐酸多奈哌齐口腔崩解片的含量

Quantitative Determination of Donepezil Hydrochloride Orally Disintegrating Tablets by HPLC

建立了一种测定口腔崩解片中盐酸多奈哌齐含量的高效液相色谱（HPLC）分析方法。采用C18硅烷键合硅胶为填料的色谱柱（4.6 mm×250 mm×5μm）,流动相V（甲醇）∶V（水）∶V（三氟乙酸）=75∶25∶0.2,流速为1.0 mL.min-1,检测波长为315nm。结果表明,盐酸多奈哌齐在质量浓度为3~30 mg.L-1内呈良好的线性关系（r=0.999 4）,高、中、低3个浓度的回收率分别为99.5%,99.7%,100.6%,相对标准偏差（RSD）分别为1.05%,0.91%,1.21%。耐用性实验F检验和t检验均不显著,相对标准偏差〈1%。该方法操作简便、专属性好、准确度和精密度高,耐用性好。

A HPLC method was established to determine the concentration of donepezil hydrochloride in orally disintegrating tablets. An ODS-C18 column （4.6 mm×250 mm×5μm） was used with a mobile phase of methanol-water-trifluoroacetic acid （75 ： 25 ： 0.2 in volume ratio）. The flow rate was 1.0 mL · min-1 and the detective wavelength was 315 nm. The calibration curve was linear within the range of 3--30 mg · L^-1 （r 0. 999 4）. The average recovery for high, middle, and low concentration was 99.5%, 99.7%, and 100.6%, respectively; while the RSD was 1.05%, 0.91%, and 1.21%. The results of F-test and T-test were not remarkable in durability test and RSD〈1%. The established method was proven to be convenient, exclusive, accurate, and reliable with adequate precision and durability.