Impurity profiling of paracetamol toxic impurities in pharmaceutical combination with ibuprofen and chlorzoxazone using HPLC and TLC densitometric methods

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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.
Funding Information
  • Misr University for Science & Technology

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