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目的:建立RP-HPLC法测定WF-208的含量并进行有关物质检查。方法:采用Diamonsil C18色谱柱(250 mm×4.6 mm,5μm);流动相:乙腈-甲醇-水(62∶20∶18);流速:1.0 mL.min-1;检测波长:238 nm;柱温:30℃。结果:WF-208在5.00～50.0 mg.L-1范围内线性关系良好(r=0.999 7),平均回收率为99.8%(RSD=0.3%),WF-208与有关物质得到良好的分离,检测限为20μg.L-1。结论:该方法操作简单,重复性好,专属性强,可用于WF-208原料药的含量测定和有关物质的检查。
OBJECTIVE: To establish a RP-HPLC method for the determination of WF-208 content and related substances. METHODS: Diamonsil C18 column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase was acetonitrile-methanol-water (62:20:18). The flow rate was 1.0 mL.min-1. The detection wavelength was 238 nm. : 30 ° C. RESULTS: WF-208 had a good linearity (r = 0.999 7) in the range of 5.00-50.0 mg.L-1 with an average recovery of 99.8% (RSD = 0.3%). WF- The detection limit is 20μg.L-1. Conclusion: The method is simple, reproducible, and specific, and can be used for the determination of WF-208 APIs and related substances.