摘要
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,5μm);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5～1000μg·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.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2011年第4期776-778,共3页
Chinese Journal of Pharmaceutical Analysis
