反相高效液相色谱法测定注射用卡络磺钠注射液的含量和有关物质  

Determination the content of injection for carbazochrome sodium sulfonate and its related substances by RP-HPLC

作　　者：周水根[1] 刘放[2] 

机构地区：[1]浙江省衢州市人民医院,衢州324000 [2]浙江省医学科学院药物研究所,杭州310013

出　　处：《海峡药学》2007年第10期34-36,共3页Strait Pharmaceutical Journal

摘　　要：目的建立了注射用卡络磺钠的含量及有关物质测定的RP-HPLC方法。方法采用Hypersil C18色谱柱（4．6×250mm，101μm），以0．01mol·L^1磷酸二氢铵（3．0）-乙醇（92．5：7．5）为流动相，检测波长：363nm。结果卡络磺钠在12．5—87．5μg·mL^-1浓度范围内，峰面积与浓度呈良好线性关系（1=0．9996），平均回收率为99．01％-99．50％，RSD=0．57％-0．98％。卡络磺钠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％。结论本法测定注射用卡络磺钠的含量及有关物质，方法简便、快速、结果准确，专属性好．适用于卡络磺钠及其制荆的质量控制。OBJECTIVE To establish a RP-HPLC method for the determination of ribavirin and relevant substances in ribavirin injection. METHODS A RP-HPLC method was developed. Chrom-atographic condition inclocded a Hypersil C18 colunm （4.6 × 250mm,10μm） with the mobile phase of 0.01 mol· L^-1 NH4HEPO4（pH =3.0）- ethnonal （92. 5： 7.5）. The UV detection wavelength was set up at 363 nm. RESULTS The linearity of piracetam was shown in range of 12.5 -87.5 μg · mL^-1 （γ=0. 9996）. The recovery rate was 99. 01% -99.05% with RSD = 0. 57% - 0. 98%. The peak of ribavirin and its related substances were separated completely. The LOD in 2.5 ng. CONCLUSION This simple and reliable method is applied to quantify ribavirin injection and its relevant substances and can be used to controll ribavirin and its preparations.

关 键 词：卡络磺钠 反相高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]