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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-10,40~120μm,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40.10~180.45μg.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。
Objective To establish a method for the determination of piperacillin in piperacillin and tazobactam sodium for injection. Methods using gel chromatography. The chromatographic conditions were as follows: Column: Sephadex G-10 as filler, SephadexTM G-10, 40-120 μm, 400 mm × 13 mm; Mobile phase A: 0.01 mol·L-1 Phosphate buffer, mobile phase B: water; flow rate: 1.0 mL.min-1, detection wavelength: 254 nm. Results The linear range of piperacillin polymer was 40.10 ~ 180.45μg.mL-1 (r = 0.999 6). Conclusion The method is simple and easy, can basically ensure that all polymer impurities are excluded, to meet the needs of drug quality control.