Determination of Principal Component and Related Substances in Chlorhexidine Gluconate Solution by HPLC
Objective To establish a high-performance liquid chromatography(HPLC)method for determining the principal component and related substances in Chlorhexidine Gluconate Solution.Methods The chromatographic column was the Capcell PAK C18 column(250 mm × 4.6 mm,5 μm),the mobile phase was sodium octanesulfonate solution-acetonitrile(gradient elution),the flow rate was 1.0 mL/min,the detection wavelength was 254 nm,the column temperature was 35℃,and the injection volume was 20 μL.Results The linear ranges of chlorhexidine gluconate and specific impurity p-chloroaniline were 0.050-0.15 mg/mL and 0.001 0-0.010 mg/mL(r=0.999 8,0.999 9)respectively.The limits of quantification of the above two components were 0.7,0.5 μg/mL,and the limits of detection were 0.3,0.2 μg/mL respectively.The RSDs of precision,stability and repeatability tests were all lower than 2.0％.The average recovery rates of the above two components were 99.50％and 101.71％with RSDs of 0.45％and 0.92％(n=6)respectively.The average contents of chlorhexidine gluconate and p-chloroaniline in three batches of samples were 20.33％and 0.11％respectively,with an average total impurity of 2.20％.Conclusion The established method is easy,precise,stable and repeatable,which can be used for the determination of principal component and related substances in Chlorhexidine Gluconate Solution.
万方数据
维普
