Investigation of acetaminophen content in over-the-counter medicine sold in Johor Bahru, Malaysia

Abstract

The market of counterfeit medicine is slowly growing making more people to be exposed with these kind products. Counterfeit medicine can bring many adverse effects to health as well as social and economic wise. The purpose of this study is to investigate the content of over-the-counter (OTC) paracetamol that were sold in Johor Bahru area. With the growing market for substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC) products including medicinal products, the statuses of these paracetamol tablets sold in market can raise some doubts. For that matter, generic OTC paracetamol 650 mg tablets brand A was chosen to be investigated. The tablets were sampled from three different type of premises namely convenient stores X, pharmacies and traditional medicine stores in four different municipal districts of Majlis Bandaraya Johor Bahru (MBJB): Pulai, Tebrau, Johor Bahru and Pasir Gudang. A few examinations and analyses were conducted to achieve this goal: a) qualitative screening examinations of product packaging (hologram and blister packaging) using Video Spectral Comparator (VSC) instrument to distinguish any SSFFC products, b) chemical profiling the ingredients of the products using Attenuated Total Reflectance – Fourier Transform Infrared (ATR-FTIR) spectroscopy to detect the presence of active pharmaceutical ingredient (API) and c) quantitative analysis of the amount of API using High Performance Liquid Chromatography coupled with Diode-Array Detector (HPLC-DAD) and the method was validated. Visual inspection of the packaging showed that apart from sample PGKU 2, all samples came from genuine source was suggested. The second screening process using ATR-FTIR found that all samples contained API as claimed (within the range of 95-105%). HPLC-DAD findings showed that the content of paracetamol could be divided into three; 1) within the range (625.14 – 671.62 mg), 2) below the range (400.87 – 616.73 mg) and 3) above the range (700.53 – 1147.50 mg). Based on these findings, each of the sample then was classified into three categories of SSFFC, that were substandard, unregistered/unlicensed and falsified. No sample was identified as unregistered/unlicensed. One sample, PGKU 2 was classified as falsified meanwhile the remaining samples were identified as substandard. In conclusion, the output of this study can be used to regulate and pharmaceutical companies and to monitor the SSFFC market.