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高效液相色谱法测定对乙酰氨基酚注射液有关物质

Determination of the related substances in paracetamol injection by HPLC
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摘要 目的:建立高效液相色谱法测定对乙酰氨基酚注射液的有关物质。方法:采用Alltima C18色谱柱,流动相为0.05 mol.L-1醋酸铵溶液-甲醇(85∶15),检测波长245 nm。结果:对乙酰氨基酚与其杂质能完全分离,已知杂质对氨基酚在2.40~191.84 ng线性关系良好(r=0.9999),平均回收率为99.8%,RSD=0.91%(n=6)。结论:所用方法简便、快速、准确,可用于对乙酰氨基酚注射液的质量控制。 Objective:To establish a method for the determination of rataled substances in paracetamol injection by HPLC.Metheds:Alltima C18 colomn was used (250 mm×4.6 mm,5 μm),the mobile phase used was 0.05 mol·L^-1 ammonium acetate solutionmethanol (85:15),the detection wavelength was 284 nm.Results:There was a good seperation for paracetamol and other related substances.These was a good linear relationship of p-aminophenol in the 2.40-191.84 ng (0.9999),and the average recovery was 99.8%.The limit of detection was 5 μg·ml^-1.Conclusion :The method is rapid, sensitive, accurate and effective for testing related substances in paracetamol injection and for its content determination.
出处 《现代医药卫生》 2008年第17期2556-2557,共2页 Journal of Modern Medicine & Health
关键词 高效液相色谱法 对乙酰氨基酚注射液 有关物质 HPLC Paracetamol injection Related substance
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