| 凝胶色谱法测定注射用头孢美唑钠的聚合物 |
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| 引用本文： | 丁玉莲,杜文革,蔡蓉,黄晓军. 凝胶色谱法测定注射用头孢美唑钠的聚合物[J]. 广东药学院学报, 2012, 28(5): 526-528 |
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| 作者姓名： | 丁玉莲 杜文革 蔡蓉 黄晓军 |
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| 作者单位： | 1. 内蒙古巴彦淖尔市医院,内蒙古巴彦淖尔,015000
2. 深圳立健药业有限公司,广东深圳,518109 |
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| 摘 要： | 目的 建立凝胶色谱法测定注射用头孢美唑钠中聚合物的方法。方法 采用分子排阻凝胶色谱进行测定，色谱柱为用葡聚糖凝胶G-10（40～120 μm）填充的玻璃柱；流动相A为pH7.0的0.02 mol/L磷酸盐缓冲液[0.02 mol/L Na2HPO4-0.02 mol/L NaH2PO4 （体积比61︰39）]，流动相B为纯化水；流速为1.5 mL/min；检测波长为254 nm。结果 采用本法对3批注射用头孢美唑钠中聚合物含量进行测定，结果均小于0.5％。结论 本方法简便、灵敏度高、重复性好，可用于注射用头孢美唑钠中聚合物的测定。
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| 关 键 词： | 注射用头孢美唑钠 凝胶色谱法 聚合物 |
Determination of the polymer in Cefmetazole Sodium for Injection by gel chromatography |
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| DING Yu-lian , DU Wen-ge , CAI Rong , HUANG Xiao-jun. Determination of the polymer in Cefmetazole Sodium for Injection by gel chromatography[J]. Academic Journal of Guangdong College of Pharmacy, 2012, 28(5): 526-528 |
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| Authors: | DING Yu-lian DU Wen-ge CAI Rong HUANG Xiao-jun |
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| Affiliation: | 1.Inner Mongolia Bayannaoer Hospital,Bayannaoer 015000,China;2.Shenzhen Lijian Pharmaceutical Company Limited,Shenzhen 518109,China) |
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| Abstract: | Objective To establish a method for the determination of the polymer in Cefmetazole Sodium for Injection.Methods Size exclusion gel chromatography was performed on the Sephadex G-10（40-120 μm） column.The mobile phase was consisted of A： 0.02 mol/L phosphate buffer of pH 7.0 [0.02 mol/L dibasic sodium phosphate-0.02 mol/L sodium dihydrogen phosphate（61∶39）] and B： water.The flow rate was 1.5 mL/min and the detection wavelength was 254 nm.Results The polymer in three batches of samples were all less than 0.5%.Conclusion The method is simple,sensitive and reproducible.It can be used to determine the polymer in Cefmetazole Sodium for Injection. |
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| Keywords: | Cefmetazole Sodium for Injection gel chromatography polymer |
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