高效分子排阻色谱法测定注射用头孢匹胺钠中聚合物的含量  

Determination of polymers in cefpiramide sodium for injection by HPSEC

作　　者：郭艳娟[1] 郭福庆[1] 

机构地区：[1]天津市药品检验所,天津300070

出　　处：《天津药学》2015年第2期21-24,共4页Tianjin Pharmacy

摘　　要：目的：建立高效分子排阻色谱法测定注射用头孢匹胺钠中聚合物的含量。方法：采用TSK-GEL G2000SWXL色谱柱（7.8 mm×300 mm）;以磷酸盐缓冲液（p H 7.0）[0.01 mol/L磷酸氢二钠-0.01 mol/L磷酸二氢钠溶液（61∶39）]-乙腈（97.5∶2.5）为流动相;检测波长231 nm;柱温30℃;流速0.8 ml/min;进样量10μl。结果：头孢匹胺在1.962 5～19.624 5μg/ml范围内与峰面积呈良好的线性关系（r=1.000 0）,最低检出浓度0.08μg/ml。结论：建立的方法简单、快速、灵敏度高,可有效控制产品的质量。Objective： To establish an HPSEC method for determination of the polymer in cefpiramide sodium for injection.Method： The analysis was carried out using a TSK- GEL G2000 SWXLchromatographic column（7. 8 mm × 300 mm） with the mobile phase containing 97. 5% of acetonitrile and 2. 5% of 0. 01 mol / L phosphate buffer solution [containing 0. 01 mol / L disodium hydrogen phosphate and 0. 01 mol / L sodium dihydrogen phosphate（61∶ 39）,p H 7. 0]. The detective wavelength was set at 231 nm and the temperature of the column at 30 ℃. The flow rate was 0. 8 ml / min with 10 μl of the sample to be injected into the HPLC. Results： The linear range of cefpiramide sodium was 1. 9625 ～ 19. 6245 μg / ml（ r = 1. 000 0）,and LOD was 0. 08 μg / ml.Conclusion： The method is simple and selective for controlling the quality of the product effectively.

关 键 词：注射用头孢匹胺钠 高分子聚合物 TSK-GEL G2000SWXL凝胶色谱柱 

分 类 号：R927.2[医药卫生—药学]