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离子交换色谱法测定对乙酰氨基酚片中对氨基酚含量 被引量:9

Determination of Relative Impurity 4-aminophenol in Paracetamol Tablet by IEC
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摘要 目的测定对乙酰氨基酚原料和片剂中的有关物质对氨基酚。方法离子交换色谱法,采用DionexIonpacCG12分离柱,淋洗液为80 mmol/L H2SO4溶液(内含3%CH3CN,作为有机改性剂),紫外检测波长265nm。结果对氨基酚质量浓度在0.2~50.0mg/L范围内与峰面积线性关系良好(r=0.9997),最低检测限为0.2961μg/L(S/N=3)。结论所用方法准确、灵敏、简便,可用于对乙酰氨基酚原料和片剂中有关物质对氨基酚的测定。 Objective To establish a method for the determination of 4- aminophenol in the raw materials and tablets of paraeetamol by IEC with UV detection. Methods The chromatographic separation was achieved on a Dionex Ionpae CG12 column. The eluent was the mixed solution containing 80 mmol/L H2SO4 and 3% CH3CN. The ultraviolet detection wavelength was 265 nm. Results The correlation coefficient of calibration curves in the range 0.2-50.0 mg/L for 4-aminopehenol was 0. 999 7. The lowest detectable limits for 4- aminophenol was 0. 296 1 ug/L( S/N = 3). Conclusion The proposed method enables accurate, sensitive, rapid analysis for 4- aminophenol in the raw materials and tablets of paracetamol.
出处 《中国药业》 CAS 2008年第17期15-16,共2页 China Pharmaceuticals
关键词 离子交换色谱法 对乙酰氨基酚 对氨基酚 有关物质 IEC paracetamol 4 - aminophenol related substance
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