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

Objective:To establish a method of content determination and assay of related substances in cytidine disodium triphosphate(CTP-Na2) injection by HPLC.Methods:The C18 column 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 computation was performed with peak area external reference method.Results:The linear range of cytidine disodium triphosphate was 90-1800 mg·L-1(r=0.9997),and the recovery rate(n=9) was 101.4%.The sample solution was stable 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.