BMC Chem. 2025 Apr 24;19(1):110. doi: 10.1186/s13065-025-01466-6.
ABSTRACT
This work presents two methods for the simultaneous determination of ibuprofen (IBU), paracetamol (PAR), and chlorzoxazone (CHZ) in the presence of three PAR impurities: p-aminophenol (PAP), p-nitrophenol (PNP), and p-chloroacetanilide (PCA). Furthermore, both methods attempt to quantify these hazardous impurities. The first method is a thin layer chromatography densitometric method (TLC), where separation was achieved on silica gel 60 F254 plates using a mobile phase consisting of chloroform, toluene, ethanol, and ammonia (7.0: 1.0: 1.6: 0.2, by volume). Densitometric detection was performed at 220.0 nm. The second method is a high-performance liquid chromatographic method (HPLC), in which the analytes were separated on an Xterra C8 column (150 × 4.6 mm, 5 µm) using an isocratic mobile phase of acetonitrile and phosphate buffer (pH 7.5) in a 30:70 (v/v) ratio. The UV detector was set at 220.0 nm, and the flow rate was maintained at 0.7 mL/min. Both methods were validated following ICH guidelines and successfully applied to the determination of IBU, PAR, and CHZ in their commercial tablet formulations. A statistical comparison with a previously reported method confirmed no discernible differences in the results, demonstrating the reliability and accuracy of the proposed techniques.
PMID:40275344 | DOI:10.1186/s13065-025-01466-6
