Determination of High Molecular Weight Impurities of Cefotiam Hydrochloride for Injection by HPSEC Method
10.3870/j.issn.1004-0781.2017.02.021
- VernacularTitle:高效分子排阻色谱法测定注射用盐酸头孢替安高分子杂质
- Author:
Dousheng ZHANG
;
Jin LI
;
Yan WANG
;
Changqin HU
- Keywords:
Cefotiam hydrochloride for injection;
Chromatography,high performance size esclusion;
Impurities,high molecular weight
- From:
Herald of Medicine
2017;36(2):202-204
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish a high performance size esclusion chromatography (HPSEC) method for the determination of high molecular weight impurities of cefotiam hydrochloride for injection.Methods A TSK G2000 SWXL column(7.8 mm × 30 cm,5μm) was used,the mobile phase consisting of phosphate budder solution [0.1 mol·L-1 disodium hyrogen phosphate-0.1 mol·L-1 sodium dihydrogen phosphate (61:39)],the flow rate was 0.7 mL· min-1,the detection wavelength was 254 nm,the column temperature was 30 ℃,the injection volume was 20 μL,and the concentration of polymers was quantified by external standard method.Results For HPSEC method,the calibration curves were linear in the range of 5.0-25.0 μg·mL-1 for cefotiam,and the LOD and LOQ was 0.1 μg·mL-1 and 0.246 μg· mL-1,the RSD for replicate for injections of reference solution was 0.50％,the sample solution was not stable in room temperature.Conclusion The method has high separation efficiency and good specificity,which provides reference for the further study of the polymer of cefotiam hydrochloride for injection.
