HPLC测定注射用三磷酸胞苷二钠的含量  

Determination of Cytidine disodium triphosphate for injection by HPLC

作　　者：赵璇[1] 游畅 郜昭慧 张雪艳 周长明[1] ZHAO Xuan;YOU Chang;GAO Zhaohui;ZHANG Xueyan;ZHOU Changming(Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,NMPA Key Laboratory for Research and Evaluation of Generic Drugs,Beijing Institute for Drug Control,Beijing,102206 P.R.China)

机构地区：[1]北京市药品检验所国家药品监督管理局仿制药研究与评价重点实验室中药成分分析与生物评价北京市重点实验室,北京102206

出　　处：《华西药学杂志》2020年第3期309-312,共4页West China Journal of Pharmaceutical Sciences

摘　　要：目的以胞苷为对照测定注射用三磷酸胞苷二钠的含量。方法采用Kromasil 100-5 C_(18)色谱柱(250 mm×4.6 mm,5μm),流动相为含反相离子对试剂的磷酸盐缓冲液,流速1.0 mL·min^(-1),检测波长271 nm,柱温35℃,以胞苷为对照品,按峰面积外标法计算三磷酸胞苷二钠的含量。结果 0.093~1.8601 mg·mL^(-1)三磷酸胞苷二钠与峰面积的线性关系良好(r=0.9997),平均回收率为99.60%,RSD=1.32%(n=9)。结论所用方法操作简便,方法准确、快速、专属性强,适用于注射用三磷酸胞苷二钠的质量控制。OBJECTIVE To determine the content of Cytidine disodium triphosphate for injection uses cytidine as control.METHODS The test was performed in Kromasil 100-5 C18 column(250 mm×4.6 mm,5μm)under the elution of phosphate buffer with reverse phase ion-pair reagent.The flow rate was 1.0 mL·min-1,the detection wavelength was set at 271 nm,and the column temperature was 35℃.Cytidine was used as control to calculate the content of Cytidine disodium triphosphate.RESULTS A good linear relationship was obtained between the peak areas and the concentrations of Cytidine disodium triphosphate in the range from 0.093 to 1.8601 mg·mL-1(r=0.9997).The average recovery was 99.60%with the RSD of 1.32%(n=9).CONCLUSION The newly established method is simple,stable and reliability,which can be used for the quality control of cytidine disodium triphosphate for injection.

关 键 词：注射用三磷酸胞苷二钠 胞苷 含量测定 外标法 高效液相色谱法 离子对试剂 药品质量标准 质量控制 

分 类 号：R917[医药卫生—药物分析学]