首页|离子色谱法测定依达拉奉注射液中亚硫酸氢钠的含量

离子色谱法测定依达拉奉注射液中亚硫酸氢钠的含量

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目的:建立离子色谱法测定依达拉奉注射液中亚硫酸氢钠的含量.方法:用过氧化氢溶液将不稳定的亚硫酸根氧化为在水中更为稳定的硫酸根,使用离子色谱仪进行检测,以10 mmol·L-1氢氧化钾溶液作淋洗液,色谱柱为Dionex IonPAC AS11-HC,250 mm × 4 mm,5 μm,并连接与分析柱填料相同的保护柱,柱温25 ℃,流速1.0 mL·min-1,进样体积20 μL.结果:在试验条件下,硫酸根在2.5~15 µg·mL-1范围内具有良好的线性关系,线性相关系数为0.999 7.方法 检出限为8ng·mL-1,定量限为20 ng·mL-1,样品加标回收率为99.29%~101.18%.结论:与传统的化学反应显色-紫外分光光度法相比,离子色谱法操作简便,方法检出限低,检测过程中样品更为稳定,测定结果可靠,再现性良好,适合大批量快速样品检测.
Determination of Sodium Bisulfite in Edaravone Injection by Ion Chromatography
Objective:An ion chromatography method was established to determine the content of sodium bisulfite in edaravone injec-tion.Methods:Using hydrogen peroxide solution to oxidize unstable sulfite to more stable sulfate in water,using an ion chromatograph for detection.Using 10 mmol·L-1 potassium hydroxide solution as eluent.The chromatographic column is Dionex IonPAC AS11-HC,250 mm × 4 mm,5μm.And connect a protective column with the same packing as the analysis column,with a column temperature of 25 ℃,a flow rate of 1.0 mL·min-1,and an injection volume of 20 μL.Results:Under experimental conditions,there is a good line-ar relationship within the range of 2.5 μg·mL-1 to 15 μg·mL-1,with a linear correlation coefficient of 0.999 7.The detection limit of the method is 8 ng·mL-1,the quantitative limit is 20 ng·mL-1,and the recovery rate of sample spiking is 99.29%-101.18%.Conclusion:Compared with the traditional chemical reaction colorimetry ultraviolet spectrophotometry,ion chromatography is easy to op-erate,has a low detection limit,and the sample is more stable during the detection process.The determination results are reliable and have good reproducibility,making it suitable for rapid sample detction in large quantities.

EdaravoneIon chromatographySodium bisulfiteSulfate

邵冉薇、戴震、贾文君

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南京市食品药品监督检验院,江苏南京 210000

依达拉奉 离子色谱法 亚硫酸氢钠 硫酸根

江苏省药品监管科学研究计划

202240

2024

中国药物评价
国家食品药品监督管理局信息中心

中国药物评价

影响因子:1.09
ISSN:2095-3593
年,卷(期):2024.41(1)
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