高效液相色谱法测定碳酸氢钠注射液中乙二胺四乙酸二钠

Determination of disodium ethylenediamine tetraacetate in sodium bicarbonate injection by HPLC

建立碳酸氢钠注射液中乙二胺四乙酸二钠的高效液相色谱测定方法。采用葡聚糖凝胶G-10色谱柱,以水为流动相,用高效液相色谱法测定碳酸氢钠注射液中乙二胺四乙酸二钠的含量。乙二胺四乙酸二钠的质量在0.1758~17.58μg的范围内与色谱峰面积线性关系良好,相关系数为0.9991,乙二胺四乙酸二钠的检出限为6.31μg/L。测定结果的相对标准偏差为0.89%(n=6),加标回收率为97.2%。该方法操作简单、准确、重现性好,可有效地控制碳酸氢钠注射液的质量。

HPLC method for determining of disodium ethylenediamine tetraacetate in sodium bicarbonate injection was established.The content of disodium ethylenediamine tetraacetate was determined by using the glucan gel G-10 as a column and water as the mobile phase.The mass of disodium ethylenediamine tetraacetate had linear relation with the chromatograph area in the range of 0.1758-17.58μg with the correlation coefficient of 0.9991.The detection limit of isodium ethylenediamine tetraacetate was 6.31μg/L,the relative standard deviation of the detection results was 0.89%(n=6),and the standard addition recovery was 97.2%.The method is simple,accurate and reproducible,which can be used to control the quality of sodium bicarbonate injection.