Content Determination of Polymer in Acitve Pharmacentical lngredient Cefatrizine Propylene Glycol by High Performance Size Exclusion Chromatography / 中国药房

ABSTRACT

OBJECTIVE:To establish a method for the content determination of polymer in cefatrizine propylene glycol. METHODS:High performance sephadex gel chromatography was performed on the column of Sephadex G-10 with mobile phase A of 0.01 mol/L phosphate buffer [0.01 mol/L Disodium hydrogen phosphate solution-0.01 mol/L Sodium dihydrogen phosphate solution (61∶39,V/V)](pH7.0)and mobile phase B of water at a flow rate of 1.0 ml/min,the detection wavelength was 254 nm,column temperature was 30℃,and volume injection was 200μl. RESULTS:The linear range of polymer was 2.07-103.30 mg/ml(r=0.999 4);the limit of quantitation of 10.4 ng,limit of detection was 4.1 ng;RSDs of precision and reprodicibility tests were lower than 3%. CONCLUSIONS:The method is specific with high sensitivity and good reproducibility,and can be used for the content determination of polymer in active pharmacentical ingredient cefatrizine propylene glycol.