HPLC法测定盐酸多奈哌齐口腔崩解片的含量

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。

Quantitative Determination of Donepezil Hydrochloride Orally Disintegrating Tablets by HPLC

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×5 μm) 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.