Potential application of near infrared spectroscopy in quality monitoring of drugs with acetylsalicylic acid as active substence

Svaki dio procesa proizvodnje tableta je strogo reguliran od regulatornih agencija u svrhu dobivanja ponovljivog proizvoda s minimalnim rizicima po ljudsko zdravlje. U tu svrhu važno je imati brzu i jednostavnu analitičku metodu koja će omogućiti preciznu analizu procesa proizvodnje. Cilj ovoga rada bio je ispitati potencijal primjene blisko infracrvene spektroskopije (NIRs) u praćenju kvalitete lijekova. U ovom radu razvijeni su kemometrijski modeli za određivanja koncentracije acetilsalicilne kiseline u tabletama dostupnim na hrvatskom tržištu. NIRs u kombinaciji s umjetnim neuronskim mrežama (ANN) za tablete/prahove s vrijednosti većom od 99 % pokazao je iznimnu sposobnost određivanja koncentracije acetilsalicilne kiseline i vrsti tableta/praha, dok je kolorimetrija samo prikazala grupiranje pojedinih tableta odnosno prahova prema boji. NIRs u kombinaciji s ANN uspio je u rasponu od 99 do najmanje 91% povezati koncentraciju acetilsalicilne kiseline, vrijednosti izmjerene električnom vodljivošću i ukupnim otopljenim tvarima za tekuće uzorke u kojima je bila različita koncentracija acetilsalicilne kiseline.Each part of the tablet production process is strictly regulated by regulatory agencies for the purpose of obtaining a repeatable product with minimal risks to human health. Therefore, it is important to have a quick analytical method that will enable a precise analysis. The aim of this study was to examine the potential application of near-infrared spectroscopy (NIRs) in drug quality monitoring. In this work, chemometric models for determination of acetylsalicylic acid concentration in tablets available on the Croatian market were developed. NIRs in combination with artificial neural networks (ANN) for tablets/powders showed exceptional ability (99 %) for determination of acetylsalicylic acid concentration and tablets/powder type, while colorimetry only showed the classification of individual tablets/powders. For liquid samples NIRs in combination with ANN was able to correlate the concentration of acetylsalicylic acid, values measured by electrical conductivity and total dissolved solids with 99 % to at least 91% accuracy