离子色谱法测定羧甲基淀粉钠中氯乙酸的残留量___

Objective:To establish a method of ion chromatography for determination of chloroacetic acid in sodium carboxymethyl starch(CMC-Na).Methods: An ion chromatography was developed, and an IonPacAS11 anion chromatography column(4.0 mm×250 mm) with an AG-11 guard column(4.0 mm×50 mm) was adopted, with the eluent of 10 mmol·L^-1 potassium hydroxide solution. The flow rate was 1.0 mL·min^-1, and the detector was conductivity detector. Results: Chloroacetic acid in CMC-Na and chloridion were separated completely. The calibration curve of chloroacetic acid showed a good linear relationship in the range of 0.02-18.42 μg·mL^-1(r=1.000);The average recovery of chloroacetic acid in CMC-Na was 101.7%(n=9).The LOD of chloroacetic acid was 0.15 ng. Conclusion:The method is accurate,reliable,and can be used for the determination of residue of chloroacetic acid in CMC-Na and other pharmaceutical excipients.