HPLC法测定三磷酸胞苷二钠注射液的有关物质和含量  

HPLC determination and assay of related substances in cytidine disodium triphosphate injection

作　　者：张彤[1] 周长明[1] 韩南银[2] 

机构地区：[1]北京市药品检验所,北京100035 [2]北京大学医学部,北京100091

出　　处：《药物分析杂志》2013年第1期154-158,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立用HPLC测定三磷酸胞苷二钠注射液的有关物质和含量的方法。方法:采用C18色谱柱,以含反相离子对试剂的磷酸盐缓冲液为流动相,流速为1.0 mL·min-1,检测波长为280 nm,柱温30℃,有关物质和三磷酸胞苷二钠的含量按峰面积以外标法计算。结果:三磷酸胞苷二钠浓度在90～1800 mg·L-1范围内线性关系良好(r=0.9997);平均回收率(n=9)为101.4%;供试品溶液在25 h内的稳定性良好(RSD=0.9%),定量限为7.4 ng。结论:该方法适用于三磷酸胞苷二钠注射液的质量控制。不同厂家的产品质量存在差异。Objective：To establish a method of content determination and assay of related substances in cytidine dis- odium triphosphate（ CTP- Na2 ） injection by HPLC. Methods ：The C lsCOlumn was used as the analytical column, the mobile phase was composed of reversed phase ion - pair reagent and phosphate buffer with the flow rate of 1.0 mL . min-1 ,the detection wavelength was set at 280 nm,and the column temperature was set at 30 ℃ ;The content compu- tation was performed with peak area external reference method. Results：The linear range of cytidine disodium triphos- phate was 90 -1800 mg . L-1 （r =0. 9997） ,and the recovery rate（n =9） was 101.4%. The sample solution was sta- ble within 25 hours（RSD =0. 9% ） ,the limit of quantitation was 7.4 ng. Conclusion： The method can be applied to quality control of cytidine disodium triphosphate. The product quality of different manufacturers has great difference.

关 键 词：三磷酸胞苷二钠 核苷酸类衍生物 辅酶类药物 有关物质 降解产物 离子对试剂 高效液相色谱法含量测定 

分 类 号：R917[医药卫生—药物分析学]