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首页> 外文期刊>Journal of chromatography, B. Analytical technologies in the biomedical and life sciences >Ion chromatography of azide in pharmaceutical protein samples with high chloride concentration using suppressed conductivity detection
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Ion chromatography of azide in pharmaceutical protein samples with high chloride concentration using suppressed conductivity detection

机译：抑制电导检测的高氯离子浓度药物蛋白质样品中叠氮化物的离子色谱法

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摘要

Methods based on reversed-phase liquid chromatography with UV detection of 4-nitrobenzoyl- or 3,5-dinitrobenzoyl azide derivatives lack in accuracy and stability of derivatives to be applied for azide determination in pharmaceutical protein samples with high sodium chloride concentrations. This paper describes a sensitive and selective ion chromatographic method, with simple sample preparation and suppressed conductivity detection, developed for trace determination of azide in protein samples containing sodium chloride in concentrations as high as 11.6 g L-1. Anion exchange stationary phase with quaternary alkyl amine functional groups and gradient elation with sodium hydroxide enabled good resolution of anions with similar retention times: azide, bromide and nitrate, as well as chloride whose retention time was shorter than azide's. Anions with high affinity to stationary phase (phosphate and citrate) were also eluted within acceptable analysis time of 32 min. The stability of sample solutions and the method selectivity, accuracy, precision and sensitivity satisfied the validation criteria of international organizations competent for pharmaceutical industry. The detection and quantitation limit ranges of sodium azide in protein samples were 0.007-0.02 mg Land 0.02-0.06 mg L-1, respectively. Both limits increased with the concentration of sodium chloride. (C) 2008 Elsevier B.V. All rights reserved.
机译：基于反相液相色谱并用UV检测4-硝基苯甲酰基-或3,5-二硝基苯甲酰基叠氮化物衍生物的方法缺乏用于高氯化钠浓度的药物蛋白质样品中叠氮化物测定的衍生物的准确性和稳定性。本文介绍了一种灵敏且选择性的离子色谱方法，该方法具有简单的样品制备和抑制电导率检测的功能，该方法用于痕量测定含氯化钠浓度高达11.6 g L-1的蛋白质样品中的叠氮化物。具有季烷基胺官能团的阴离子交换固定相以及与氢氧化钠的梯度洗脱可以使具有相似保留时间的阴离子（叠氮化物，溴化物和硝酸盐以及保留时间短于叠氮化物的氯化物）具有良好的分离度。在32分钟的可接受分析时间内，还洗脱了对固定相具有高亲和力的阴离子（磷酸根和柠檬酸根）。样品溶液的稳定性以及方法的选择性，准确性，精密度和灵敏度满足了国际制药行业组织的验证标准。蛋白质样品中叠氮化钠的检出限和定量限分别为0.007-0.02 mg Land 0.02-0.06 mg L-1。两种极限都随氯化钠浓度的增加而增加。 （C）2008 Elsevier B.V.保留所有权利。

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