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

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.