盐酸多奈哌齐片中有效成分含量分析检测方案(液相色谱柱)

HPLCDATA SHEETF140228D*Standard solution was prepared from Donepezil hydrochloride supplied as a reagent for laboratory use.www. fnrs turrzanlt. com.cn 下木八沙儿墟酸墟锭·細粒(日本薬局方記記条件) Donepezil hydrochloride tablets and fine granules (The Japanese Pharmacopoeia) Standard solution* (0.2 mg/mL Donepezil hydrochloride) Systemsuitability requirement Result Theoretical plate number(Donepezil) 24000 7600 Tailing factor (Donepezil) ≤1.5 1.13 Relative standard deviation of the peak area (n=6)(Donepezil) ≤1.0% 0.10% Donepezil hydrochloride Column ：YMC-Pack ODS-A(5 pm， 30 nm)150 X4.6 mml.D. Eluentit ：acetonitrile/water/perchloric acid (350/650/1)containing 2.5 g of sodium1-decansulfonateFlow rate ： 0.9mL/min(adjust the flow rate so that the retention time of donepezil is about 11 min)Temperature ：35℃Detection ： UV at 271 nmInjection ：20pL(The Japanese Pharmacopoeia 16th； Uniformity of dosage units) 网 色谱条件见谱图