Safety Assay of Marketed Paracetamol Tablet by ‎Using Raman Spectroscopy Technique

Abstract

Controlling and identifying the degraded products and impurities in the drug materials are the key issues in assuring the stability and quality of drugs throughout their shelf life, from both pharmaceutical and toxicological perspectives. Although, the drugs are packaged in a controlled environment at room temperature (25°C; 60% Relative Humidity (RH)), they may be exposed to elevated temperature and humidity during use, especially in regions with diverse climatic conditions. This study investigates the degradation of the Active Pharmaceutical Ingredient (API) of paracetamol tablet due to storage in inappropriate environmental conditions. The empirical method relies on the investigation of the respective Raman spectra of two groups of tablets; bare and packaged tablets. First, the accuracy of the analytical method used is evaluated, showing acceptable precision and accuracy within the range of the pharmacopeia guidelines with the Relative Standard Deviation (RSD)of less than ±5%. The tablet packaging effectively prevents moisture absorption; however, the API degradation process due to increased temperature is inevitable, and noticeable degradation in both tablet groups takes place after 30 minutes. The resulting data is validated using paracetamol tablets produced by different companies. Exposure to elevated temperatures leads to a noticeable degradation of paracetamol across different brands, all following similar trends. Also, the inappropriate environmental conditions result in the formation of the toxic compound P-aminophenol within the tablet. As the API degradation progresses, the corresponding characteristic Raman peak of P-aminophenol becomes more pronounced. Therefore, Raman spectroscopy technique can be operationalized as a standard method for online controlling of drug quality in both production lines and in the market.