Dejaegher B, Bloomfield M S, Smeyers-Verbeke J, Vander Heyden Y
Analytical Chemistry and Pharmaceutical Technology, Pharmaceutical Institute, Vrije Universiteit Brussel (VUB), Laarbeeklaan 103, 1090 Brussels, Belgium.
Talanta. 2008 Mar 15;75(1):258-65. doi: 10.1016/j.talanta.2007.11.029. Epub 2007 Nov 17.
4-aminophenol (4-AP) is the primary degradation product of paracetamol (PARA). According to the European Pharmacopoeia, 50 ppm 4-AP/PARA is the specification limit of 4-aminophenol in paracetamol drug substance. For drug products, often higher specification limits, such as 1000 ppm 4-AP/PARA are applied. This paper describes a fluorimetric method to quantify the low amount of this degradant (50 ppm) in a pharmaceutical preparation, i.e. in paracetamol tablets. The fluorimetric method was validated and the linearity, precision, trueness, range, limit of detection and limit of quantification were determined. They were found acceptable to assay the low amounts of 4-aminophenol in paracetamol tablets.
4-氨基苯酚（4-AP）是对乙酰氨基酚（PARA）的主要降解产物。根据欧洲药典，对乙酰氨基酚原料药中4-氨基苯酚的规格限度为50 ppm 4-AP/PARA。对于药品，通常会采用更高的规格限度，例如1000 ppm 4-AP/PARA。本文描述了一种荧光分析法，用于定量药物制剂（即对乙酰氨基酚片）中这种低含量降解产物（50 ppm）。该荧光分析法经过了验证，并测定了线性、精密度、准确性、范围、检测限和定量限。结果发现，这些指标对于测定对乙酰氨基酚片中低含量的4-氨基苯酚是可接受的。
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