孟鲁司特钠片中含量测定检测方案(液相色谱柱)

HPLCDATA ：SHEET 毛少于儿力又卜十卜少儿锭(米国薬局方原案記載条件) Montelukast sodium tablets (The draft for The United States Pharmacopoeia) H150501B (A) Dissolution： Standard solution*1(5.4 ug/mL Montelukast) Systemsuitability requirement Result Tailing factor(Montelukast) ≤1.5 1.08 Relative standarddevition of peakarea (n=5)(Montelukast) ≤2.0% 0.05% (B)Uniformity of dosage units： Standard solution(0.039 mg/mL Montelukast) Systemsuitability requirement Result Tailing factor(Montelukast) ≤1.5 1.15 Relative standarddevition of peakarea (n=5)(Montelukast) ≤2.0% 0.06% (C) Uniformity of dosage units： Sample solution(0.04mg/mL Montelukast) Column ： YMC-Pack Ph (5 um， 12 nm)100X3.0 mml.D.Eluent ： acetonitrile/water/TFA (500/500/2)Flow rate ： 0.9 mL/minTemperature ： 50℃Detection ： UV at 389 nmInjection ：A) 20 pL， B)，C) 10 pL (The draft for The United States Pharmacopoeia 40th； Dissolution， Uniformity of dosage units) All Standard solutions ware prepared from Montelukast sodium salt hydrate supplied as a reagent for laboratory use.Sample solution was prepared from Montelukast sodium tablets. 色谱条件见谱图。