替米沙坦中有关物质检测方案(液相色谱柱)

HPLC DATA ：SHEET 于儿三艹儿夕>(日本薬局方原案記載条件)Telmisartan (The draft for the Japanese Pharmacopoeia) E130717G A) Standard solution*' Telmisartan B) Test solution**1(2.5 mg/mL Telmisartan) System suitabilityrequirement Result Theoretical plate number(Telmisartan) 245000 56100 Tailing factor(Telmisartan) ≤1.2 1.06 Relative standarddeviation of the peak area(Telmisartan) ≤5.0% 0.62% Column YMC-Triart C18 (5 um， 12 nm) 125X4.0 mml.D. Eluent ：A) buffer (pH 3.0)* B) acetonitrile/methanol (4 /1) 30-80%B (0-25 min) *Dissolve 2.0 g of KH2PO4 and 3.4 g of sodium 1-pentanesulfonate in 1000 mL water， adjust pH 3.0 with H3PO4(1→10) Flow rate ： 1.0mL/min Temperature ： 40℃ Detection ： UV at 230nm Injection ：2uL (The draft for the Japanese Pharmacopoeia 16th； Related compounds) * Standard and Test solutions were prepared from Telmisartan supplied as a reagent for laboratory use. 替米沙坦有关物质检查的液相色谱条件色谱柱：YMC-Triart C18，5um, 4.0×125mm流动相：A）缓冲液 (pH3.0)               B）乙腈-甲醇 (4/1)               梯度洗脱：30-80%B（0-25min）流速：1.0ml/min柱温：40℃检测器：UV（230nm）溶液浓度：对照液0.025mg/ml  测试液2.5mg/ml进样体积：2μL