离子色谱法同时测定注射用丹参(冻干)中有机酸和无机阴离子

目的: 建立能够同时测定注射用丹参(冻干)中有机酸(乳酸、乙酸、甲酸、琥珀酸和草酸)和无机阴离子(氯离子和硝酸根离子)含量的离子色谱法。 方法: 以Ion Pac AS11-HC阴离子交换柱分离,1~50 mmol·L^-1氢氧化钾溶液梯度淋洗,ASRS 300型抑制器电导检测器检测,自循环抑制模式。 结果: 5个有机酸及2个无机阴离子基本达到分离,线性关系良好,相关系数分别在0.9996~0.9999和0.9997~0.9999,平均回收率分别在92.4%~105.1%和102.0%~103.2%。 结论: 所建立的方法快速、准确、简便、实用,可用于注射用丹参(冻干)中有机酸和无机阴离子的含量测定和质量控制。

Objective: To establish an ion chromatography method for simultaneous determination of five organic acids(lactic acid,acetic acid,formic acid,succinic acid and oxalic acid) and two inorganic anions(chloridion and nitrate) in Danshen for injection(lyophilized powder). Methods: Five organic acids and two inorganic anions were determined by anion exchange column Ion Pac AS11-HC,eluted by gradient hydroxide potassium(1-50 mmol·L^-1) and identified by suppressed conductivity detector ASRS 300 with self-circulation suppression mode. Results: Good resolution can be achieved among the above mentioned five organic acids and two inorganic anions.Their linear correlations over the investigated concentration were in the range of 0.9996-0.9999 and 0.9997-0.9999,while the average recoveries were 92.4%-105.1% and 102.0%-103.2%,respectively. Conclusion: The ion chromatography method is fast,accurate,simple,reliable and applicable for the assay and quality control of organic acids and inorganic anions in Danshen for injection(lyophilized powder).

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