硫酸依替米星注射液中亚硫酸钠的离子色谱法测定

Determination of Sodium Sulfite in Etimicin Sulfate Injection by Ion Chromatography

建立了离子色谱法快速测定硫酸依替米星注射液中的亚硫酸钠。采用Ion Pac AS17-C型阴离子分析柱,以10~24 mmol/L氢氧化钾溶液为淋洗液,电导检测器检测。加入10倍量次磷酸钠作为稳定剂,并用0.1 mol/L氢氧化钠溶液调节注射液至p H 9.0防止亚硫酸盐被氧化,稀释后直接进样。亚硫酸钠在2~32μg/ml范围内线性关系良好,定量限为0.055μg/ml。平均回收率为94.8%~101.6%,日内、日间RSD均小于3%。

An ion chromatography method was established for the determination of sodium sulfite in etimicin sulfate injection. An IonPac AS17-C type anion analytical column was used, with 10--24 mmol/L potassium hydroxide solution as the eluent, and with the application of a conductivity detector. A ten times volume sodium hypophosphite was added as anti-oxidant of sulfite, and then the solution was adjusted to pH 9.0 with 0.1 mol/L sodium hydroxide solution for the prevention of oxidation. It was directly injected after dilution. It was linear for sodium sulfite in the range of 2-- 32 μg/ml, with LOQ of 0.055 μg/ml. The average recoveries were 94.8 %--101.6 %, with intra- and inter-day RSDs less than 3 %.