反相高效液相色谱法测定利巴韦林注射液的含量和有关物质

Determination of ribavirin and related substances in ribavir injection by RP-HPLC

目的建立了利巴韦林注射液的含量及有关物质测定的RP-HPLC方法。方法采用HypersilC18（4．6mm×250mm，10μm）色谱柱，水为流动相，检测波长：207nm。结果利巴韦林在20．26—80．96mg·L^-1浓度范围内，峰面积与浓度呈良好线性关系（r=0．9998），平均回收率为98．97％-101．10％，RSD=0．48％-1．53％。利巴韦林及其有关物质得到基线分离，方法的最低检测量为2．5ng，控制总杂质量不得过1．0％。结论本法测定利巴韦林注射液的含量及有关物质，方法简便、快速、结果准确，专属性好，适用于利巴韦林及其制剂的质量控制。

Aim To establish a RP-HPLC method for the determination of ribavirin and relevant substances in ribavirin injection. Methods A RP-HPLC method was developed. Chromatographic condition included a hypersil C18 column with the mobile phase of water. The UV detection wavelength was set up at 207 nm. Results The linearity of piracetam was shown in the range of 20.26 - 80.96 mg ·L^-1 （ r = 0. 999 8）. The recovery rate was 98.97% - 101.10% with RSD being 0.48% - 1.53%. The peak of ribavirin and its related substances were separated completely. The LOD is 0.25 ng. Conclusion This simple and reliable method is applied to determine ribavirin injection and its relevant substances and can be used to control ribavirin and its preparations.