Validation thin layer chromatography for the determination of acetaminophen in tablets and comparison with a pharmacopeial method.
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.
Department of Analytical Chemistry, Faculty of Pharmacy, Medical University of Silesia, PL-4 Jagiellońska Street, 41-200 Sosnowiec, Poland.
Alina
A
Pyka
Marika
M
Budzisz
Małgorzata
M
Dołowy
D000082:Acetaminophen / Q000032:analysis*; D002138:Calibration; D002855:Chromatography, Thin Layer / Q000379:methods*; D003720:Densitometry; D010602:Pharmacopoeias as Topic; D012015:Reference Standards; D015203:Reproducibility of Results; D013607:Tablets
D013607:Tablets; D000082:Acetaminophen