Inorganic Profiling of Amoxicillin Drugs in Ghana Using Proton Induced X-Ray Emission (Pixe) Analysis
Date
2017-07
Authors
Journal Title
Journal ISSN
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Publisher
University of Ghana
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.
Description
Keywords
Ghana, Amoxicillin Drugs, X-Ray Emission (Pixe) Analysis, Inorganic Profiling, Proton Induced