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| Determination of paracetamol impurity content by HPLC |
| Zhi Yongqiang, Liu Xiaolian, Ma Ningning, Han Xiao, Yang Cangjun, Wang Junkai,
Dai Aiguo, Hao Xinting |
| Hebei Jiheng Pharmaceutical Corporation Ltd., Hengshui 053400, China |
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Abstract This paper provides a high-performance liquid phase detection method of acetaminophen dimer impurities in acetaminophen, which can quantitatively analyze the content of the impurity. The detection method is as follows chromatographic column: octane silane bonded silica gel chromatcolumn (250 mm 4.6 mm, 5 m); flow phase: phosphate buffer-methanol (90∶10) as flow phase; flow rate: 1.0 ml/min; column temperature: 40 ℃; sample intake: 20 μl; detection wavelength: 245 nm. The proposed method has a good linear relationship to the acetaminophen impurities, with a relative error of less than 2%.The determination of the impurity content by the HPLC method is simple, fast, accurate and highly sensitive to improve the quality of the acetaminophen products.
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