HPLC测定利巴韦林葡萄糖注射液中5-羟甲基糠醛的含量

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

关键词:  利巴韦林葡萄糖注射液  5-羟甲基糠醛  高效液相色谱法  加权最小二乘法

Key words:  ribavirin and glucose injection  5-HMF  HPLC  weighted least square method

摘要:

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DiamonsilTM C18柱(250 mm×4.6 mm，5 μm)；流动相：甲醇-水(30∶70)；检测波长：284 nm；流速：1.0 mL·min^-1；进样量：20 µL；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0.099 4~7.949 µg·mL^-1和0.002 0~0.198 7 µg·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= 0.999 0和0.999 8)，定量限和检测限分别达0.04 ng和0.012 ng，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。

Abstract:

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 mm×4.6 mm, 5 μm) 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 µg·mL^-1 and 0.002 0-0.198 7 µg·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.