阿立哌唑中含量/有关物质检测方案(液相色谱柱)

HPLC DATA ：SHEET 了J匕才亏少一儿(米国薬局方記載条件)Aripiprazole (The United States Pharmacopeia) H140204A (A) Standard solution"， Sample solution(0.1 mg/mL Aripiprazole) 1 mAU： 350 300 250 200 Systemsuitability requirement Result Relative standard deviation of the peak area(Aripiprazole) ≤1.0% 0.13% H140129A 0 0 5 10 15 20 25 30 min (B) System suitability solution 司公(1.0 pg/mL Aripiprazole， 1.0 pg/mL Aripirazole related compound F)限有 Aripiprazole Aripiprazole related compound F Column ：YMC-Pack ODS-A (3 um， 12 nm) 100X4.6 mml.D Eluent ：A) acetonitrile/0.05% TFA (10/90) B) acetonitrile/0.05% TFA (90/10) 20%B (0-2 min)， 20-35%B (2-10 min)，35-90%B (10-20 min)， 90%B (20-25 min)， 90-20%B (25-26min)，20%B (26-35min) Flow rate ： 1.2mL/min Temperature ：25℃ Detection . ： UV at 254 nm Injection ：20 pL (The United States Pharmacopeia 36th； Assay， Impurities) .All solutions were prepared from aripiprazole and aripiprazole related compound F ：supplied as1aa reagent forlaboratory use. 按美国药典36版规定的液相色谱方法，用YMC-Pack ODS-A色谱柱（规格3μm，4.6×100mm P/N：AA12S03-1046WT）测定阿立哌唑的含量，拖尾因子及相对标准偏差等均符合规定。