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  • Validation thin layer chromatography for the determination of acetaminophen in tablets and comparison with a pharmacopeial method.

Validation thin layer chromatography for the determination of acetaminophen in tablets and comparison with a pharmacopeial method.

BioMed research international (2013-09-26)
Alina Pyka, Marika Budzisz, Małgorzata Dołowy
摘要

Adsorption thin layer chromatography (NP-TLC) with densitometry has been established for the identification and the quantification of acetaminophen in three leading commercial products of pharmaceutical tablets coded as brand: P1 (Product no. 1), P2 (Product no. 2), and P3 (Product no. 3). Applied chromatographic conditions have separated acetaminophen from its related substances, namely, 4-aminophenol and and 4'-chloroacetanilide. UV densitometry was performed in absorbance mode at 248 nm. The presented method was validated by specificity, range, linearity, accuracy, precision, detection limit, quantitative limit, and robustness. The TLC-densitometric method was also compared with a pharmacopeial UV-spectrophotometric method for the assay of acetaminophen, and the results confirmed statistically that the NP-TLC-densitometric method can be used as a substitute method. It could be said that the validated NP-TLC-densitometric method is suitable for the routine analysis of acetaminophen in quantity control laboratories.

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对乙酰氨基酚相关化合物J, Pharmaceutical Secondary Standard; Certified Reference Material
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