Strategy for identification of possible medicine falsification using tablet formulations “Acetylsalicylic acid” and “Paracetamol” as example

Abstract

The protocol for identification of possible falsified medicines has been proposed. The protocol comprises four steps: 1) identification of the active pharmaceutical ingredients in one drug of every trade name by performing functional group qualitative reactions; 2) quantification of the active pharmaceutical ingredients in drugs studied during the first step of the protocol; 3) investigation of all available drugs by Infrared and/or Raman spectroscopy and visual spectra interpretation; 4) processing of spectral data matrix of all drugs by chemometric techniques. The protocol was applied to screen tablet formulations of trade names «Acetylsalicylic acid» (two manufactures, six series) and «Paracetamol» (four manufactures, four series). Raman spectra of tablets and principal component analysis were used to extract the useful information on drug classification.