Objective:To establish a method for the determination of citrate ion content in porcine fibrinogen of biological products by high performance liquid chromatography(HPLC),and the method was validated.Methods:A refractive index detector and Agilent Hi-plex H column(7.7 mm×300 mm,8 μm)were used and the HPLC was performed with 4 mmol/L sulfuric acid solution as mobile phase at column temperature 50℃,flow rate 0.8 mL/min,and sample volume 5 μL.Results:The standard curve was linear over the range of 5.01-15.04 mmol/L with linear correlation coefficient r 0.999 5.The average recoveries at low,medium and high concentrations were 104.0%,102.8%and 97.6%,respectively and the overall average recovery was 101.5%(n=9),and the overall relative standard deviation(RSD)was 3.16%(n=9).The RSD obtained from the intermediate precision was only 0.75%(n=12)and the durability ratio was 99.71%-100.49%.Conclusion:This method has strong specificity,good accuracy,precision,and durability,and is suitable for the determination of citric acid ion content in porcine fibrinogen.
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