HPLC测定利巴韦林葡萄糖注射液中5-羟甲基糠醛的含量

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。MC18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：20儿；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0．04职和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。

Determination of 5-Hydroxymethylfurfural in Ribavirin and Glucose Injection by HPLC

OBJECTIVE To establish an HPLC method for the determination of 5-hydroxymethylfurfural（5-HMF） in ribavirin and glucose injection. METHODS The HPLC method was performed on a Diamonsil C18 column（250 mmx4.6 mm, 5 pm） with 284 nm as the detection wavelength, and methanol-water（30 ： 70） was used as mobile phase. The column temperature was room temperature, and the flow rate was 1.0 mL＇min-1. RESULTS Ribavirin and excipients did not interfere with the determination of 5-HMF. The regression results which was based on weighted least square method showed a good linearity within the range of 0.099 4-7.949 p.g.mL-1 and 0.002 0-0.198 7μg·mL-1 （r=0.999 0 and 0.999 8, respectively） for 5-HMF. The LOQ and LOD of 5-HMF were 0.04 and 0.012 ng, respectively, and the average recovery was 100.4% with RSD of 1.8% （n=6）.CONCLUSION The HPLC method was accurate, sensitive and suitable for determining the content of 5-HMF in ribavirin and glucose injection.