Danica Agbaba1, Darija Obradović1, Marija Čarapić2
1Department of Pharmaceutical Chemistry, Faculty of Pharmacy-University of Belgrade, Vojvode Stepe 450, 11000 Belgrade, Serbia
2Medicines and Medical Devices Agency of Serbia, Vojvode Stepe 450, 11000 Belgrade, Serbia
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Thin Layer Chromatography (TLC) is one of the oldest chromatographic techniques which has widely been used in research on small molecules of natural and synthetic origin with physiological or pharamacological importance. Regulatory requirements for monitoring of quality and safety of substances which remain in pharmaceutical use throughout their whole life cycle (i.e., not only in human body, but also in the environment) become increasingly more strict. This trend is accompanied by development of instrumentation to establish novel and better conditions for drug analysis. The Quality by Design (QbD) methodology is going to be implemented by pharmaceutical industry in production and quality control of active pharmaceutical substances (APIs) and dosage formulations, although it still is not an obligatory regulatory demand. Nowdays, classical yet DoE-supported, or eco-friendly TLC/HPTLC methods are used for qualitative and quantitative pharmaceutical analysis, which includes identification, purity and chiral purity testing, dissolution, and content and uniformity of content with APIs as raw materials and in the dosage form.
