Abstract
Studies carried out by X-ray and thermal analysis confirmed that acetaminophen (paracetamol), declared by the manufacturers as an Active Pharmaceutical Ingredient (API), was present in all studied medicinal drugs. Positions of diffraction lines (2θ angles) of the studied drugs were consistent with standards for acetaminophen, available in the ICDD PDF database Release 2008. values were lower than 0.2°, confirming the authenticity of the studied drugs. Also, the values of interplanar distances dhkl for the examined samples were consistent with those present in the ICDD. Presence of acetaminophen crystalising in the monoclinic system (form I) was confirmed. Various line intensities for API were observed in the obtained diffraction patterns, indicating presence of the preferred orientation of the crystallites in the examined samples. Thermal analysis of the studied substances confirmed the results obtained by X-ray analysis. Drugs containing only acetaminophen as an API have melting point close to that of pure acetaminophen. It was found that presence of other active and auxiliary substances affected the shapes and positions of endothermal peaks significantly. A broadening of endothermal peaks and their shift towards lower temperatures were observed accompanying an increase in the contents of additional substances being “impurities” in relation to the API. The results obtained by a combination of the two methods, X-ray powder diffraction (XRPD) and differential scanning calorimetry/thermogravimetry (DSC/TGA), may be useful in determination of abnormalities which can occur in pharmaceutical preparations, e.g., for distinguishing original drugs and forged products, detection of the presence of a proper polymorphic form or too low content of the active substance in the investigated drug.
Highlights
Self-medication has become very popular in recent times, and drug manufacturers are constantly striving to make more and more drugs available over the counter
Differential scanning calorimetry/thermogravimetry (DSC/thermogravimetric analysis (TGA)), may be useful in determination of abnormalities which can occur in pharmaceutical preparations, e.g., for distinguishing original drugs and forged products, detection of the presence of a proper polymorphic form or too low content of the active substance in the investigated drug
Qualitative phase analysis used a comparison of experimental diffraction data such as 2θ diffraction angles, dhkl interplanar distances, and relative intensities, with the data from the ICDD database
Summary
Self-medication has become very popular in recent times, and drug manufacturers are constantly striving to make more and more drugs available over the counter. Such drugs include acetaminophen (ACP, paracetamol), belonging to p-aminophenol derivatives, having a formula CH3 CONHC6 H4 OH (C8 H9 NO2 ). ACP occurs in two polymorphic variations: monoclinic (form I) and orthorhombic (form II) [1]. Form I is more thermodynamically stable than form II [2]. This compound is included in the composition of more than 300 pharmaceutical preparations. Advantages of ACP include rapid action, high effectiveness, low toxicity and very rare
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