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

Sephadex Chromatographic System for Determination of Polymer in Piperacillin Sodium/Tazobactam Sodium for Injection

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。

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.