中国药房2016，Vol.27Issue(24)：3434-3436,3.DOI:10.6039/j.issn.1001-0408.2016.24.38
高效分子排阻色谱法测定丙二醇头孢曲嗪原料药中聚合物的含量
Content Determination of Polymer in Acitve Pharmacentical lngredient Cefatrizine Propylene Glycol by High Performance Size Exclusion Chromatography
李喆宇 1张静霞 1王宇驰 1张春然 1徐明琴 1王瑛瑛 1董宏波 1王婷 2唐克慧1
作者信息
- 1. 成都大学四川抗菌素工业研究所/成都抗生素创制工程技术研究中心，成都 610052
- 2. 滇虹药业集团股份有限公司，昆明 650106
- 折叠
摘要
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.关键词
丙二醇头孢曲嗪/聚合物/高效分子排阻色谱法Key words
Cefatrizine propylene glycol/Polymer/High performance size exclusion chromatography分类
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李喆宇,张静霞,王宇驰,张春然,徐明琴,王瑛瑛,董宏波,王婷,唐克慧..高效分子排阻色谱法测定丙二醇头孢曲嗪原料药中聚合物的含量[J].中国药房,2016,27(24):3434-3436,3.
