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建立注射用复方头孢西丁钠中两种有效成分的定量分析方法。采用Kromasil C18色谱柱(250mm×4.6mm,5μm),以乙腈-磷酸二氢钾(0.03mol.L-1)-10%四丁基氢氧化铵(35∶63.5∶1.5,V/V/V),用85%的磷酸调pH=4为流动相,流速1.0mL.min-1,进样量10μL,柱温30℃,在230nm的波长下进行他唑巴坦、头孢西丁两种物质的定量分析。他唑巴坦、头孢西丁浓度分别在0.125—0.50mg.mL-1(r=0.9998)、0.5—2.0mg.mL-1(r=0.9999)范围内与峰面积呈良好线性关系;方法的回收率(n=9)分别为99.7%、100.2%;样品相对标准偏差分别为1.5%、0.2%;稳定性实验表明上述两种成分在室温条件下8h内稳定。本法首次建立了注射用复方头孢西丁钠的含量测定方法,该法快速、简便、准确,重复性好,适用于该药物的含量测定。
To establish a method for quantitative analysis of two active ingredients in compound cefoxitin sodium for injection. The residue was purified on a Kromasil C18 column (250 mm × 4.6 mm, 5 μm) using acetonitrile-potassium dihydrogen phosphate (0.03 mol·L -1) -10% tetrabutylammonium hydroxide (35:63.5:1.5 V / V / V) With 85% phosphoric acid adjusted to pH = 4 as mobile phase, flow rate 1.0mL.min-1, injection volume 10μL, column temperature 30 ℃, at 230nm wavelength tazobactam, cefoxitin two quantitative analysis. The concentrations of tazobactam and cefoxitin showed a good linear relationship with the peak area in the range of 0.125-0.50 mg.mL-1 (r = 0.9998) and 0.5-2.0 mg.mL-1 (r = 0.9999) The recoveries (n = 9) were 99.7% and 100.2%, respectively. The relative standard deviations of the samples were 1.5% and 0.2%, respectively. The stability experiments showed that the above two components were stable within 8 hours at room temperature. The method for the first time established the method for the determination of compound cefoxitin sodium for injection. The method is rapid, simple, accurate and reproducible, and is suitable for the determination of the content of the drug.