反相高效液相色谱法测定利巴韦林葡萄糖注射液的含量和有关物质  

Determination of Ribavirin and Glucose Injection and its Relevant Substances by RP-HPLC

作　　者：刘放[1] 孙洁胤[1] 周芝芳[1] 

机构地区：[1]浙江省医学科学院药物研究所,杭州310013

出　　处：《浙江省医学科学院学报》2007年第4期15-18,共4页

摘　　要：目的建立测定利巴韦林葡萄糖注射液的含量及有关物质的反相高效液相色谱法。方法采用DIAMONSIL C18柱（4．6×250mm，10μm），水为流动相，检测波长：207nm，流速：1mL／min。结果利巴韦林在10．20μg／mL～61．32μg／mL浓度范围内，峰面积与浓度呈良好线性关系（γ=0．9996），平均回收率为98．97％～99．68％，RSD=0.30％～0．65％，利巴韦林及其有关物质得到基线分离，最低检测量为0.1ng，控制总杂质量不超过1.0％。结论本方法简便、快速、准确，适用于利巴韦林及其制剂的质量控制。Objective To establish a RP-HPLC method for the determination of ribavirin and glucose injection and its relevant substances. Methods The RP-HPLC conditions as follows： a DIAMONSIL C18 colunm （250×4.6mm, 10μm） ,water as a mobile phase with flow of 1.0mL/min, the UV detection wavelength at 207nm. Results The linearity of ribavirin was shown in the range of 10.20μg/mL～61.321μg/mL（γ=0.9996）. The mean recovery rate was 98.97%～99.68% with RSD=0.30%～0.65%.The peak of ribavirin and its related substances were separated completely. The LOD was in 0.1ng. Conclusion The method was simple,rapid and accurate, and could be used to control ribavirin and its preparations.

关 键 词：利巴韦林 利巴韦林葡萄糖注射液 有关物质 反相高效液相色谱法 

分 类 号：R978.7[医药卫生—药品] R927.2[医药卫生—药学]