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目的:采用反相高效液相色谱法建立YF-13-1原料药质量控制的方法。方法:色谱柱为KROMASIL-C18(4.6 mm×200 mm,5μm),流动相为0.02 mol.L-1磷酸二氢钾溶液(磷酸调节pH 4.5)-甲醇(40∶60),流速为1.0 mL.min-1,室温,检测波长235 nm。结果:YF-13-1与中间体及各降解产物分离良好,YF-13-1浓度在1.05～520.34 mg.L-1范围时与峰面积呈良好线性关系(r=0.9995,n=7),日内、日间精密度RSD均在5%以下,检测限0.5μg.L-1。结论:该方法可用于YF-13-1原料药的含量测定和有关物质检查。
Objective: To establish a method for quality control of YF-13-1 API by RP-HPLC. Methods: The chromatographic column was KROMASIL-C18 (4.6 mm × 200 mm, 5 μm) with a mobile phase of 0.02 mol·L-1, potassium dihydrogen phosphate solution adjusted to pH 4.5 with phosphoric acid (40:60) and the flow rate was 1.0 mL .min-1, room temperature, detection wavelength 235 nm. Results: YF-13-1 was well separated from the intermediates and its degradation products. YF-13-1 had a good linear relationship with the peak area in the range of 1.05-520.34 mg.L-1 (r = 0.9995, n = 7) , The intra-day and inter-day precision RSD were below 5%, the detection limit was 0.5μg.L-1. Conclusion: This method can be used for the determination of YF-13-1 APIs and related substances.