毛细管电泳法测定注射用头孢哌酮钠他唑巴坦钠中目标成分

建立了毛细管区带电泳法同时测定注射用头孢哌酮钠他唑巴坦钠中目标成分含量的方法。采用石英毛细管(75 cm×75 μm i.d.,有效长度63 cm),以40 mmol/L硼砂溶液为背景电解质(BGE),以氢氯噻嗪为内标,分离电压12.0 kV,检测波长220 nm,重力进样10 s(高度10 cm)。实验结果表明,头孢哌酮钠与他唑巴坦钠分别在0.25～3.96 g/L和0.062～0.99 g/L范围内呈良好的线性关系,相关系数(r)分别为0.9995和0.9996。精密度和重复性均良好,相对峰面积的相对标准偏差(RSD)均小于3%,制剂在208 min内稳定,回收试验结果符合方法学要求。该方法简单、准确、耗费少、污染小,可用于注射用粉针剂头孢哌酮钠他唑巴坦钠中头孢哌酮钠和他唑巴坦钠的定量分析。

Determination of target compounds in cefoperazone sodium and tazobactam sodium for injection by capillary electrophoresis

A capillary zone electrophoresis (CZE) method was developed for the simultaneous determination of cefoperazone sodium and tazobactam sodium in the injectable powder of cefoperazone sodium and tazobactam sodium with hydrochlorothiazide as the internal standard. The operation was carried out on a quartz capillary (75 cm x 75 microm i. d. , 63 cm effective length). The electrophoretic conditions were as follows: 40 mmol/L borax solution as the back ground electrolyte (BGE), 12. 0 kV applied voltage, 220 nm as the detection wavelength; the sample solution was injected by hydraulic pressure for 10 s at the height of 10 cm. The cefoperazone and tazobactam showed good linear relationship in the ranges of 0.25-3.96 g/L and 0.062-0.99 g/L with the correlation coefficients of 0.999 5 and 0.999 6, respectively. The relative standard deviations of relative peak areas were less than 3%. The preparation was stable in 208 min. The recovery results met the methodology requirements. The method is simple, rapid, reproducible, and suitable to control the quality of cefoperazone sodium and tazobactam sodium injectable powder.