| 注射用头孢拉定聚合物测定方法的建立 |
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| 引用本文： | 罗立骏,刘映倩,杨帆,李绪伦.注射用头孢拉定聚合物测定方法的建立[J].儿科药学杂志,2014(9):50-52. |
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| 作者姓名： | 罗立骏 刘映倩 杨帆 李绪伦 |
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| 作者单位： | 重庆市食品药品检验所,重庆市药物过程与质量控制工程技术研究中心,重庆401121 |
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| 摘 要： | 目的：建立高效液相色谱法测定注射用头孢拉定聚合物的含量。方法：采用高效液相色谱法,色谱柱为TSK-GEL G2000SWXL凝胶色谱柱,流动相为pH 8.0的0.2 mol/L磷酸盐缓冲液即0.2 mol/L磷酸氢二钠溶液-0.2 mol/L磷酸二氢钠溶液（95∶5）,检测波长210 nm,柱温30℃,流速1 mL/min,进样量20μL。结果：头孢拉定对照品检测线性范围为5.21-208.57μg/mL（r=0.99997）,注射用头孢拉定聚合物检测线性范围为0.17-3.37 mg/mL（r=0.999）,聚合物定量限为0.14μg。结论：该方法测定注射用头孢拉定聚合物专属性好,快速,分离度好,可用于注射用头孢拉定聚合物的检测。
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| 关 键 词： | 注射用头孢拉定 聚合物 高效液相色谱法 |
Establishment of the Measurement Method of Injectable Cefradine Polymer |
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| Luo Lijun,Liu Yingqian,Yang Fan,Li Xulun.Establishment of the Measurement Method of Injectable Cefradine Polymer[J].Journal of Pediatric Pharmacy,2014(9):50-52. |
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| Authors: | Luo Lijun Liu Yingqian Yang Fan Li Xulun |
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| Institution: | (Chongqing Institute for Food and Drug Control, The Chongqing Institute of Medical Process and Quality Control Engineering Technology, Chongqing 401121, China) |
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| Abstract: | Objective： To establish a method to determine the injection cefradine polymer content by high-performance liquid chromatography. Methods： By using HPLC method,TSK-GEL G2000 SWXL gel column was chosen; the mobile phase was pH 8. 0 of0. 2 mol /L phosphate buffer 0. 2 mol /L disodium hydrogen phosphate solution-0. 2 mol /L sodium dihydrogen phosphate solution（95∶ 5）],the detection wave length was 210 nm,column temperature was 30 ℃,the injection volume was 20 μL. Results： The curve of cefradine was linear within a range of 5. 21 - 208. 57 μg /mL（r = 0. 99997）,the curve of injection polymer cefradine was linear within a range of0. 17 ~ 3. 37 mg /mL（r = 0. 999）,the quantification limit of polymer was 0. 14 μg. Conclusion： This method is fast,good separation can be used for cefradine polymer detection. |
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| Keywords: | Injection Cefradine Polymer HPLC |
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