Abstract

IMPURITY PROFILING OF PARACETAMOL DOSAGE FORMS USED IN MAIDUGURI METROPOLIS

Hassan Yesufu Braimah*, Abubakar Babakura Tijjani and Samuel Chabiri Amos

Abstract

Pharmaceutical impurities are those substances which co-exist with the active pharmaceutical ingredient (API) or they may develop during synthesis or ageing of both API and formulation. The presence of these impurities even in minor amounts can influence the efficacy and safety of drug. Paracetamol (N-(4-hydroxyphenyl) acetamide) also known as acetaminophen is a widely used analgesic for management of pain and fever in a variety of patients including children, pregnant women and the elderly. The aim of this work was to test for the presence of impurities in paracetamol dosage forms used in the Maiduguri metropolis by TLC and HPLC methods. For PAP detection an Intersil ODS-3V column (150 mm × 4.6 mm; 5 μm pore size) was used at the temperature of 350C, the mobile phase was methanol : water (20 : 80) using isocratic elution at the flow rate of 2 ml/min, injection volume of 10 μl and a diode array detector. For PCA detection, the chromatographic conditions were the same except the mobile phase which was methanol: water (60: 40), flow rate of 1.2 ml/min and injection volume of 20 μl. 15 samples each of paracetamol tablet and syrups were randomly selected from three different sources; hospital pharmacy, community pharmacy and drug patent stores. Using the TLC method none of the samples showed spots corresponding to PAP or PCA. Using the HPLC method, one sample of paracetamol syrup presented with a peak that corresponds to PAP and upon quantification the amount was below the limit stated by the pharmacopoeia thus the sample was accepted. None of the samples showed peak corresponding to PCA. corresponding to PCA.

Keywords: Pharmaceutical impurity, paracetamol, HPLC, TLC, PAP and PCA.