Abstract
Globalization driven by chemical and pharmaceutical industries has resulted in a large-scale investment in the research and development (R&D) of new drugs, generic drugs and medicinal products, as well as in an improvement of the existing medical therapies. In order to efficiently develop and register safe, effective and high-quality drugs, the ICH guidelines have to be followed and implemented at each stage of industrial drug production. Planar chromatography (thin-layer chromatography (TLC) and high performance thin-layer chromatography (HPTLC)) has been used for a reliable qualitative assessment of the process related and drug related organic impurities that could originate from synthesis of drugs/pharmaceutically active substances. Instrumental planar chromatography has been used to develop novel procedures for biopharmaceutical evaluation of active pharmaceutical substances and for preformulation analysis of dosage forms, cleaning validation of pharmaceutical equipment, enantioseparation, determination and purity assessment of chiral drugs, analysis of mono-component, two-component and multicomponent pharmaceuticals, and for purity assessment of pharmaceutics.
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