Reversed phase ion-pair HPLC determination of cytidine disodium triphosphate in cytidine disodium triphosphate injection

Objective:To establish a reversed phase ion-pair HPLC method for determining the concentrations of sodium cytidine triphosphate(CTP) in cytidine disodium triphosphate injection.Method:Luna ODS C_(18)(250mm× 4.60mm,5μm)column was applied,using methanol-75mmol·L~(-1) tetrabutylammonium hydroxide solution (con- rained 50 mmol·L~(-1) potassium dihydrogen phosphate,adjusted to pH 4.0 with phosphoric acid)(25:75)as mo- bile phase.Injection volume was 20μL and detection wavelength was 271nm.Result:Peak area of CTP was in a good linear correlation with injection quantity within the range of 40-200μg·mL~(-1).Regression equation was Y= 9.302×10~4X+1.000×10~6(r=0.9997).The recovery was 99.96%,RSD was 0.5%(n=6).The limit of detec- tion was 0.15ng,and the limit of quantitation was 0.5ng.Conclusion:The method has high sensitivity and repro- ductivity.It can be used for quality control of cytidine disodium triphosphate injection.It has not been reported in China for determining the concentrations of CTP in cytidine disodium triphosphate injection with reversed phase ion -pair HPLC.