| 引用本文: | 张菁,朱建平,苑华.凝胶色谱法测定注射用哌拉西林钠他唑巴坦钠中高分子聚合物[J].中国现代应用药学,2010,27(5):452-454. |
| .Sephadex Chromatographic System for Determination of Polymer in Piperacillin Sodium/Tazobactam Sodium for Injection[J].Chin J Mod Appl Pharm(中国现代应用药学),2010,27(5):452-454. |
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| 摘要: |
| 目的 建立注射用哌拉西林钠他唑巴坦钠中哌拉西林聚合物的测定方法。方法 采用凝胶色谱法。色谱条件为：色谱柱：葡聚糖凝胶G-10为填充剂RASIS柱(SephadexTM G-10，40~120 μm，400 mm×13 mm)；流动相A：pH 7.0的0.01 mol·L-1磷酸盐缓冲液，流动相B：水；流速：1.0 mL·min-1，检测波长：254 nm。结果 哌拉西林聚合物线性范围为40.10~180.45 μg·mL-1(r=0.999 6)。结论 方法简便易行，可基本保证所有高分子杂质被排阻，满足药品质量控制的需要。 |
| 关键词: 凝胶色谱法 注射用哌拉西林钠他唑巴坦钠 哌拉西林聚合物 |
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| Sephadex Chromatographic System for Determination of Polymer in Piperacillin Sodium/Tazobactam Sodium for Injection |
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ZHANG Jing ZHU Jianping YUAN Hua
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| Abstract: |
| OBJECTIVE To develop a method for determination of polymer in piperacillin sodium/tazobactam sodium for injection. METHODS Sephadex G-10 column was used with the mobile phase A of 0.01 mol·L-1 phosphate buffer (pH 7.0) and mobile phase B of water. The flow rate was 1.0 mL·min-1 and the wavelength was 254 nm. RESULTS The linear range of polmer in piperacillin sodium/tazobactam sodium for injection was 40.10-180.45 μg·mL-1(r=0.999 6). CONCLUSION The method was convenient and accurate, and can meet the requirements of drug quality control. |
| Key words: sephadex G-10 chromatographic system piperacillin sodium/tazobactam sodium for injection piperacillin polymer |
