反相高效液相色谱法测定氟非尼酮的含量

目的: 建立测定氟非尼酮含量的高效液相色谱法。 方法: 采用Waters Symmetry C₁₈ 柱(250 mm×4.6 mm,5 μm);流动相为乙腈-0.1%三乙胺水溶液(40∶ 60,磷酸调至pH 4.0),流速:1.0 mL·min^-1 ,检测波长:310 nm,柱温:35 ℃。 结果: 氟非尼酮的浓度在5~1000 μg·mL^-1 范围内线性良好(r=0.9997);方法的最低检测限为5 ng(S/N =3);高、中、低3个浓度的平均回收率(n=5)分别为99.7%(RSD=0.23%),101.7%(RSD=0.19%),100.3%(RSD=0.12%);各杂质峰与主峰达到基线分离。 结论: 此方法操作简便、灵敏、准确,重复性好,适用于氟非尼酮的含量测定,可作为该药质量控制的检测方法。

Objective: To establish an RP-HPLC method for determination of the content of fluorofenidone. Methods: The column was Waters Symmetry C₁₈ (250 mm×4.6 mm,5 μm),the mobile phase consisted of acetonitrile-0.1% triethylamine solution (40∶ 60) with a flow rate of 1.0 mL·min^-1,the UV detection wavelength was set at 310 nm. Results: The calibration curve was linear within the range of 5 to 1000 μg·mL^-1 (r=0.9997);the lowest limit determination was 5 ng (S/N =3).The mean recoveries (n=5) of high,middle and low concentration were 99.7% (RSD=0.23%),101.7% (RSD=0.19%),100.3% (RSD=0.12%);the chromatographic peaks of fluorofenidone and its related substances were well isolated. Conclusion: The method is simple,selective,accurate and reproducible.It is suitable for determination of the content of fluorofenidone.