Background
Chromatographic behavior of different substances in normal and reversed phases is an interesting area in the scientific community.
Objective
The work aimed to optimize and validate chromatographic separation methods for simultaneous determination of paracetamol (PAR) and phenylephrine HCl (PHE) in presence of PAR impurities namely, P-Aminophenol (PAP), P-Nitrophenol (PNP), Acetanilide (ACT) and P-Chloroacetanilide (CAC) with further quantification of these toxic impurities.
Methods
Thin layer chromatography based on normal phase separation was carried out on aluminum sheet of silica gel 60 F254 using ethanol:chloroform:ammonia as a developing system, followed by densitometric measurements. While, high-performance liquid chromatography (HPLC) is based on reversed phase separation using C18 column against acetonitrile:phosphate buffer pH 5 as a mobile phase.
Results
PAR and PHE were determined by TLC-Densitometric method in concentration ranges of 3 – 25 µg/band and 0.1 – 3 µg/band, respectively and determined by HPLC method over concentration ranges of 5 – 400 µg/mL and 2 – 80 µg/mL for PAR and PHE, respectively. Both methods were optimized and validated. Furthermore, they were successfully applied for pharmaceutical formulations with precision <2%. Moreover, results of statistical comparison with the official methods confirm the claims of methods’ validity.
Conclusion
Two eco-friendly chromatographic methods were developed to determine PAR and PHE in their binary mixtures, pharmaceutical formulation and in presence of PAR related impurities with further quantification of these toxic impurities.
Highlights
These simple chromatographic methods are the first methods developed for simultaneous determination of PAR and PHE in presence of PAR related impurities.
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