高效液相色谱法测定莫达非尼及其胶囊剂含量

HPLC Determination of Modafinil and Its Capsules

目的:测定莫达非尼原料药及其胶囊剂的含量。方法:采用高效液相色谱法。色谱柱为Phenomenex ODS(150mm×4.6mm,5μm),柱温30℃,流动相为甲醇-50mmoL·L^(-1)甲酸(50:50,pH=2.5),流速1.0mL·min^(-1),UV检测波长225nm。结果:莫达非尼浓度在1.0～20μg·mL^(-1)范围标准曲线线性良好,最低检测浓度0.5μg·L^(-1),日内RSD为1.8％(n=5),日间RSD为2.0％(n=5),加样回收率98.0％～99.6％(n=3)。结论:本法简便快速,准确可靠,可用于莫达非尼及其胶囊剂含量测定等相关研究。

Objective: Determination of modafinil and its capsules. Method: A simple HPLC method for deter-mination of modafinil is established. The analytical column is Phenomenex ODS 150 mm ×4. 6 mm, 5 μm. Meth-anol and 50 mmol·L-1 formic acid (50: 50, pH =2. 5) is used as mobile phase, flow rate at 1. 0 mL · min-1. The eluate is monitored at 225 nm. Results: The Standard curve is linear within the range of 1.0 - 20μg · mL -1. The detection limit of modafinil is 0. 5 μg · mL-1. The within - day RSD and between - day RSD is 1. 8 % (n = 5 ) and 2. 0% ( n = 5 ) , respectively. The recovery of modafinil determination is 98. 0% - 99. 6% ( n = 3). Conclusion: This method is simple, accurate and reliable for deternination of modafinil and its capsules.