Counterfeit paracetamol tablet analysis and its discrimination using fourier transform infrared spectroscopy coupled with chemometrics techniques

Abstract

Paracetamol tablet is a well-known over the counter medicine and is widely available for consumers. For that reason, the originality of paracetamol tablets sold in the market is questionable. Even though pharmaceutical measures for ensuring that the manufactured medicines would comply fully with the standards were taken, cases involving counterfeit paracetamol products have been increasingly reported throughout the world. Hence, this present cross-sectional research which analysed BRAND X 500 mg paracetamol tablets sampled from varying outlets of different districts in Johor appears important for the relevant authorities to understand the current status of authenticity of such product and also for consumer protection. In this research, while the quality of samples was determined based on their active pharmaceutical ingredient (API) amounts using validated High Performance liquid chromatography (HPLC), their organisation and classification were done by Fourier Transform Infrared Spectroscopy (FTIR) coupled with Principal Component Analysis (PCA) and Linear Discriminant Analysis (LDA). Quality examination of the samples indicated a variability in qualities; (1) in-range (475-525 mg), (2) lower than range (324-466 mg) and (3) higher than range (532-598 mg). These indications were made according to British Pharmacopoeia (2013) which stated that preparation of paracetamol products must have 95-105% of paracetamol content. Despite being categorically different in the amounts of paracetamol contents as well as districts and outlets, PCA and LDA showed that all the samples were convoluted into a single group, which supports the idea that all BRAND X 500 mg paracetamol tablet samples in this present research may originate from a common source/manufacturer. However, discrimination between the lower than range and the higher than range samples by PCA and LDA (accountable for 91% of variances and 93% correct classification respectively) had resulted in successful separation between them. Therefore, analysis of BRAND X 500 mg paracetamol tablet samples and their discrimination prove to be significant for providing empirically robust scientific evidence for the relevant authorities to prevent increasing flooding of its counterfeit products especially in Malaysia.