Inorganic Profiling of Amoxicillin Drugs in Ghana Using Proton Induced X-Ray Emission (Pixe) Analysis

Abstract

The increase of drug counterfeits and its unconscious use has become a major cause for concern to healthcare practitioners and relevant stakeholders. The occurrence of counterfeit or fake drugs is perceived to be a problem encountered in both developing and underdeveloped nations where Ghana is not an exemption. The lethal implications of counterfeit/fake medications are well understood to be a major challenge to the soundness of public health systems around the world, as well as a direct threat to our individual health and well-being. Sub-standard and counterfeit/fake drugs are a widespread problem in Ghana and the need to address it is eminent. The volume of drugs that require control, from the statutory organisations like Food and Drugs Authority of Ghana (FDA) and Ghana Standard Authority (GSA) is enormous, and hence the need to explore other faster analytical techniques to help control cannot be over emphasised. According to the World Health Organization (WHO), Antibiotics are the most counterfeited drugs and Amoxicillin (C16H19N3O5S) happened to be ranked first on the list. The most used and prescribed method for drug quality control analysis is the High-Performance Liquid Chromatography (HPLC) technique which accesses the quality of drugs from its Active Principal Ingredient (API) perspective. The main focus of this study is to harness additional analytical procedure to enhance the routine monitoring of the quality of some Amoxicillin drugs in Ghana from the inorganic constituent point of view. HPLC and the physical parameter tests were carried out on the samples analysed to help validate the interpretation of the inorganic element results from the PIXE technique. Two different local brands of amoxicillin and two imported amoxicillin brands were chosen for this study. A total 30 samples were analysed for this study including one (1) standard reference material (amoxicillin) acquired from a licenced pharmaceutical company in Ghana. Particle Induced X-ray Emission (PIXE) analysis of the amoxicillin standard reference material revealed ten (10 ) elements which include Al, S, K, Ca, V, Cr, Mn, Fe, Ni, and Zn. Sulphur was identified as the major element in the standard reference material and recorded concentration value of 396,805 ppm. Samples from "Kwame Nkrumah Circle", a locally manufactured brand recorded the lowest sulphur concentrations of 251,745 ppm, compared to all drugs analysed using PIXE; imported amoxicillin (395,753 ppm) and "Okaishi" locally manufactured (384,710 ppm). Additionally, the elements Cr, Mn and Fe were found to be relatively higher in the "Kwame Nkrumah Circle" sample hence raising concerns over the quality of the "Kwame Nkrumah Circle" brand. When a physical parameter test was performed on all samples, all brands with the exception of "Kwame Nkrumah Circle" passed the disintegration and dissolution test deeming the "Kwame Nkrumah Circe" brand substandard. After an HPLC test was performed for all samples, it was discovered that all the drugs analysed passed the acceptance criteria (90-120%) for drugs set by the British Pharmacopeia; with the "Kwame Nkrumah Circle" brand recording a value of 97% relatively lower than all the other samples which range from 113 to 117%. Sulphur as an active principle ingredient was correlated with the other identified elements. Strong correlations with correlation coefficients within the range 0.9936 – 0.9978 were found with the elements Cr, Mn, and Fe. Hence the elements S, Cr, Mn, and Fe lend themselves as element signature for amoxicillin medical drug. This was done to discover element signatures that will facilitate differentiating between genuine and counterfeit amoxicillin drugs. Considering the simplicity in sample preparation, the non-distractive nature of PIXE analysis, and also fast turn out in producing results. PIXE offers a considerable advantage when analysing antibiotic drugs on a large scale.

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Ghana, Amoxicillin Drugs, X-Ray Emission (Pixe) Analysis, Inorganic Profiling, Proton Induced

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