首页> 外文期刊>Electrophoresis: The Official Journal of the International Electrophoresis Society >Impurity profiling of dexamphetamine sulfate by cyclodextrin-modified microemulsion electrokinetic chromatography.
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Impurity profiling of dexamphetamine sulfate by cyclodextrin-modified microemulsion electrokinetic chromatography.

机译:通过环糊精修饰的微乳液电动色谱对硫酸右苯丙胺进行杂质分析。

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摘要

A CD-modified microemulsion electrokinetic chromatography method has been developed and validated for dexamphetamine sulfate which allows the simultaneous determination of charged and uncharged impurities of the drug including the levorotary (R)-enantiomer. The optimized background electrolyte consisted of 1.5% w/w SDS, 0.5% w/w ethyl acetate, 3.5% w/w 1-butanol, 2.5% w/w 2-propanol and 92% w/w 50 mM sodium phosphate buffer, pH 3.0, containing 5.5% w/w sulfated beta-CD. Separations were performed in a 50.2/40 cm, 50 mum id fused silica capillary at a temperature of 20 degrees C and an applied voltage of -14 kV. Carbamazepine was used as internal standard. The assay was validated in the range of 0.1-1.0% for the related substances and 0.1-5.0% for levoamphetamine based on a concentration of 3 mg/mL of dexamphetamine sulfate. The LOD of all analytes ranged between 0.05 and 0.2%. In commercial samples of dexamphetamine sulfate, levoamphetamine was found at concentrations between 3.2 and 3.8%, whereas none of the other impurities could be detected.
机译:已经开发了一种CD修饰的微乳液电动色谱方法,并已针对硫酸右苯丙胺进行了验证,该方法可以同时测定药物的带电和不带电杂质,包括左旋(R)-对映异构体。优化的背景电解质包括1.5%w / w SDS,0.5%w / w乙酸乙酯,3.5%w / w 1-丁醇,2.5%w / w 2-丙醇和92%w / w 50 mM磷酸钠缓冲液, pH 3.0,包含5.5%w / w的硫酸化β-CD。在温度为20摄氏度,施加电压为-14 kV的50.2 / 40厘米,50毫米内径熔融石英毛细管中进行分离。卡马西平用作内标。基于3 mg / mL硫酸右苯丙胺的浓度,相关物质的验证度为0.1-1.0%,左旋苯丙胺的验证度为0.1-5.0%。所有分析物的检测限为0.05%至0.2%。在商业上的硫酸右苯丙胺样品中,左苯丙胺的浓度在3.2至3.8%之间,而其他杂质均未检出。

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