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目的建立测定利巴韦林葡萄糖注射液中5-羟甲基糠醛含量的高效液相色谱法。方法采用Diamonsil TMC18柱(250mm×4.6mm,5μm);流动相:甲醇-水(30:70);检测波长:284nm;流速:1.0mL·min-1;进样量:20μL;柱温:室温。结果利巴韦林和辅料均不干扰5-羟甲基糠醛的检测,加权最小二乘法回归结果表明,在0.0994~7.949μg·mL-1和0.0020~0.1987μg·mL-1内5-羟甲基糠醛浓度与峰面积均呈现良好的线性关系(r=0.9990和0.9998),定量限和检测限分别达0.04ng和0.012ng,平均回收率为100.4%,RSD为1.8%(n=6)。结论该方法专属性强、灵敏度高、准确性好,适用于利巴韦林葡萄糖注射液中5-羟甲基糠醛的检测。
Objective To establish a HPLC method for the determination of 5-hydroxymethylfurfural in Ribavirin glucose injection. Methods: Diamonsil TMC18 column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase was methanol-water (30:70). The detection wavelength was 284 nm. The flow rate was 1.0 mL · min -1. . Results Ribavirin and excipients did not interfere with the detection of 5-hydroxymethylfurfural. The results of weighted least squares regression showed that in the range of 0.0994 ~ 7.949μg · mL-1 and 0.0020 ~ 0.1987μg · mL-1, There was a good linear relationship between the concentration of furfural and the peak area (r = 0.9990 and 0.9998). The limits of quantitation and detection limit were 0.04ng and 0.012ng, respectively. The average recovery was 100.4% and the RSD was 1.8% (n = 6). Conclusion The method is specific, sensitive and accurate. It is suitable for the detection of 5-hydroxymethylfurfural in ribavirin glucose injection.