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目的:建立HPLC-ELSD法测定他唑巴坦钠中钠离子含量。方法:采用Waters Spherisorb SCX离子色谱柱(150mm*4.6mm,5μm),以0.05mol/L醋酸铵溶液(用冰醋酸调节pH值至4.8)-甲醇(95:5,v/v)为流动相,流速为1.0ml/min,柱温为25℃,进样量为20μl,以蒸发光散射检测器检测,雾化温度为50℃,载气(氮气)压力为25psi,动力级别为100%。结果:钠离子在浓度1μg/ml~100μg/ml范围内与峰面积呈良好的幂函数关系,r=0.9998;检测限为0.5μg/ml,定量限为1.0μg/ml;加样回收率(n=3)分别为99.0%、100.6%、99.4%,RSD分别为1.5%、2.4%、0.7%。结论:本方法通用性好,专属性强,线性范围宽,耐用性好,可用于他唑巴坦钠中钠离子含量的测定。
Objective: To establish a HPLC-ELSD method for the determination of sodium ion in tazobactam sodium. METHODS: A Waters Spherisorb SCX column (150 mm × 4.6 mm, 5 μm) was used as the mobile phase in a 0.05 mol / L ammonium acetate solution (adjusted to pH 4.8 with glacial acetic acid) -methanol (95: 5, v / v) , Flow rate of 1.0ml / min, column temperature of 25 ℃, injection volume of 20μl by evaporative light scattering detector detection, atomization temperature of 50 ℃, carrier gas (nitrogen) pressure of 25psi, power level of 100%. Results: The sodium ion showed a good power function relationship with the peak area in the range of 1μg / ml ~ 100μg / ml, r = 0.9998. The detection limit was 0.5μg / ml and the limit of quantification was 1.0μg / ml. n = 3) were 99.0%, 100.6% and 99.4%, respectively. The RSDs were 1.5%, 2.4% and 0.7% respectively. Conclusion: The method has good generality, specificity, wide linear range and good durability, and can be used for the determination of sodium ion in tazobactam sodium.