Simultaneous Determination of Taurineamide and Taurine in Taurolidine by HPLC-CAD
Objective:An HPLC-CAD method was developed to simultaneously determine impurities(taurineamide and taurine)in taurolidine.Methods:A Sielc Primesep 500 column(150 mm × 4.6 mm,5μm)was used for separation in a gradient elution mode,with 10 mmol·L-1 ammonium formate solution(adjust to pH3.4 with formic acid)as mobile phase A and acetonitrile as mobile phase B.The flow rate was 1.0 mL·min-1.The column temperature was maintained at 20° C,the nebulization temperature of the detector was 35℃,and the injection volume was 10 μL.Results:The method was determined to be linear in the range of 0.225 4-3.016 0 μg·mL-1(r=0.999 1)for quantitation of taurineamide and 0.221 2-2.957 8 μg·mL-1(r=0.999 3)for taurine.Method accuracy was assessed by spiking taurineamide and taurine at three levels.The average recoveries were 102.8％and 101.8％,with the RSDs of 3.4％and 2.2％,respectively.Conclusion:The developed method was validated as per ICH guideline and found to be specific,precise,sensitive and robust,which can be used for quality control of taurolidine.
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