Determination of principal components and related substances in adenosine disodium triphosphate preparation by ion chromatography

Abstract

A new method was developed for the determination of adenosine disodium triphos- phate (ATP-Na2 ) and its related substances in ATP-Na2 preparation by ion chromatography (IC). The sample was diluted with ultrapure water and filtrated by 0.22 μm polyether sulfone filter membrance, and then analyzed by IC directly without any more pretreatment. The analysis was performed on a Dionex IonPac AS11-HC column (250 mm x 4 mm) and a guard column Ion-Pac AG11-HC (50 mm x 4 mm). A KOH eluent generator cartridge was used for gradient elution at the flow rate of 1.0 mL/min. The detection was performed by a Dionex suppressed (Dionex AERS 500 4-mm) conductivity detector. The injection volume was 10 μL. The assay was quantitatively completed by external standard method and the related substances were calculated with correction factors. The linear ranges of the method for ATP-Na2, adenosine disodium diphosphate (ADP-Na2) and adenosine disodium monophosphate (AMP-Na2) were 0.000 146-1.83 g/L (r = 0.9997), 0.000484-1.51 g/L (r = 0.9996) and 0.000426-0.804 g/L (r = 0.9999), respectively. The average recoveries of ATP-Na2 were 96.50%, 96.57% and 96.77% at three spiked levels. The limits of quantitation (S/N = 10) of ATP-Na2, ADP-Na2 and AMP-Na2 were 1.5 ng, 4.8 ng, 4.3 ng, and the limits of detection (S/N = 3) were 0.58 ng, 1.21 ng, 1.28 ng, respectively. The results demonstrated that the system has the advantages of high sensitivity, facile automation and simple sample pretreatment. The method is suitable for the quality control of adenosine disodium triphosphate preparations.