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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 a HPLC method for the determination of flurbiprofenin. METHODS: A Waters Symmetry C18 column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase consisted of acetonitrile-0.1% triethylamine in water (40:60, adjusted to pH 4.0 with phosphoric acid) at a flow rate of 1.0 mL · min -1. Wavelength: 310 nm, column temperature: 35 ° C. Results: The linear range of flufenidone was 5 ~ 1000μg · mL-1 (r = 0.9997). The minimum detection limit was 5 ng (S / N = 3) (RSD = 0.23%), 101.7% (RSD = 0.19%) and 100.3% (RSD = 0.12%). The average recovery of each impurity peak and main peak reached baseline separation. Conclusion: This method is simple, sensitive, accurate and reproducible. It is suitable for the determination of florfenicol and can be used as a quality control test method.