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

作　　者：李喆宇[1] 张静霞[1] 王宇驰 张春然[1] 徐明琴[1] 王瑛瑛[1] 董宏波[1] 王婷 唐克慧[1] LI Zheyu;ZHANG Jingxia;WANG Yuchi;ZHANG Chunran;XU Mingqin;WANG Yingying;DONG Hongbo;WANG Ting;TANG Kehui(Chengdu University Sichuan Industrial Institute of Antibiotics;Chengdu Engineering Research Center of Innovative Antibiotics,Chengdu 610052,China;Dihon Pharmaceutical Group Co.,Ltd.,Kunming 650106,China)

机构地区：[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

出　　处：《中国药房》2016年第24期3434-3436,共3页China Pharmacy

摘　　要：目的：建立测定丙二醇头孢曲嗪原料药中聚合物含量的方法。方法：采用高效分子排阻色谱法。色谱柱为SephadexG-10，流动相A为0.01mol/L磷酸盐缓冲液[0.01mol/L磷酸氢二钠溶液-0.01mol/L磷酸二氢钠溶液（61∶39，V/V）]（pH7.0），流动相B为水，流速为1.0ml/min，检测波长为254nm，柱温为30℃，进样量为200μl。结果：丙二醇头孢曲嗪原料药中聚合物的检测质量浓度线性范围为2.07～103.30μg/ml（r＝0.9994）；定量限为10.4ng、检测限为4.1ng；精密度、重复性试验的RSD＜3％。结论：该方法专属性强、灵敏度高、重复性好，可用于丙二醇头孢曲嗪原料药中聚合物的含量测定。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 of0.01 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,columntemperature was 30 ℃,and volume injection was 200 μl. 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 determinationof 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 

分 类 号：R917[医药卫生—药物分析学]