Quantitative screening of the pharmaceutical ingredient for the rapid identification of substandard and falsified medicines using reflectance infrared spectroscopy.

Graham Lawson,Sangeeta Tanna,John Ogwu,Mohammad Shahid

doi:10.1371/journal.pone.0202059

Graham Lawson, Sangeeta Tanna + Show 2 more

Open Access

https://doi.org/10.1371/journal.pone.0202059

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Journal: PloS one	Publication Date: Aug 10, 2018
Citations: 35	License type: CC BY 4.0

Affiliation: De Montfort University

Abstract

The World Health Organization suggests that approximately 10% of medicines worldwide are either falsified or substandard with higher figures in low and middle income countries. Such poor quality medicines can seriously harm patients and pose a threat to the economy worldwide. This study investigates attenuated total reflectance-fourier transform infrared (ATR-FTIR) spectroscopy as a simple and rapid method for determination of drug content in tablet dosage forms. Paracetamol was used as the model pharmaceutical ingredient. Spectra of standard mixtures of paracetamol with different excipients formed the basis for multivariate PLS based quantitative analysis of simulated tablet content using different selected infrared absorbance bands. Calibration methods using ATR-FTIR were compared with the ATR-FTIR and conventional ultraviolet spectroscopic analyses of real tablet samples and showed that the paracetamol/microcrystalline cellulose mixtures gave optimum results for all spectral bands tested. The quantitative data for band 1524–1493cm-1 was linear (R2 ˃ 0.98; LOQ ≥ 10%w/w tablet). Global examples of paracetamol tablets were tested using this protocol and 12% of the tablet samples examined was identified as substandard. Each sample analysis was completed in just a few minutes. ATR-FTIR can therefore be used in the rapid screening of tablet formulations. The simplicity of the proposed method makes it appropriate for use in low and middle income countries where analytical facilities are not available.

Highlights

The growing problem of substandard and falsified pharmaceuticals presents a serious and increasing threat to international public health and patient safety [1,2,3]
Data sufficiently reproducible to confirm the presence of paracetamol could be obtained from different analyses of a whole tablet placed on the sampling port of the ATR-fourier-transform infrared (FTIR) instrument
The overall result of this study, the identification of 7 suspect paracetamol tablet samples or 12%, is broadly in line with the World Health Organization (WHO) estimates for the general level of falsified or substandard medicines worldwide

Summary

Introduction

The growing problem of substandard and falsified pharmaceuticals presents a serious and increasing threat to international public health and patient safety [1,2,3]. Substandard medicines result from poor manufacturing and quality assurance processes and reach the public due to lax control measures whereas falsified (counterfeit) medicines are deliberately and fraudulently labelled [4]. Up to 50% of medicines purchased from the internet may be of a poor quality [10], a recent review has highlighted that it is difficult or impossible to make reliable estimations about the prevalence of falsified and substandard medicines [11] These medicines can pose a significant threat to public health and produce economic problems worldwide and there is a need for improvements in methods for both screening and monitoring medicines for such poor quality medicines

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