RP-HPLC法测定YF-13-1含量及有关物质

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,5 μm),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0.5 μg·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 develop a RP-HPLC method for the quality control of YF-13-1. Methods: The separation was performed on a KROMASIL-C₁₈ column(4.6 mm×200 mm,5 μm) with the mobile phase of 0.02 mol·L^-1 potassium dihydrogen phosphate solution (pH 4.5 adjusted by phosphoric acid)-methanol (40: 60) at a flow rate of 1.0 mL·min^-1 and the column temperature was room temperature.The UV detection was set at 235 nm. Results: YF-13-1 was separated completely from impurities.A good linearity was found over the concentration range of 1.05-520.34 mg·L^-1.The intra- and inter-day precision was lower than 5%.LOD of YF-13-1 was 0.5 μg·L^-1. Conclusion: The selective and reliable RP-HPLC method is usable for the determination of YF-13-1 and its related substances.

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