Determination of Related Substances in Adenosine Injection by HPLC

OBJECTIVE:To establish a method to determine the related substances in Adenosine injection.METHODS:HPLC method was adopted.The determination was performed on Agilent TC C18column with mobile phase consisted of acetonitrile-0.01 mol/L potassium dihydrogen phosphate(pH 5.8,12 ∶ 88)at the flow rate of 1.0 ml/min.The detection wavelength was set at 260 nm.The contents of known impurities were calculated by peak area using external standard;the contents of total impurities and single impurity were calculated by self-control method.RESULTS:The adenosine can be separated from impurities well.The linear relationships of adenosine and impurities(uridine,guanosine,inosine and adenine)were good at the range of 0.3-30 μg/ml and 0.03-3.0 μg/ml(r=0.999 8-1.000),and the detection limits were 0.03,0.21,1.20,0.21 and 0.03 ng.CONCLUSIONS:The method is simple and sensitive.It can be used to control the quality of the products.