Pharmaceutical analysis

Quality control (QC) process in pharmacy is necessary to ensure a requested level of quality of pharmaceuticals, e. i. their efficacy, safety and quality. An important part of QC method development must be a thorough method validation meeting rigorous criteria of Czech national control authority State institution for drug control (SUKL) or international authorities, such as FDA or ICH. The drug substance and all components of the drug product including API, excipients and packaging materials must be tested for the quality. Stability studies are important to define API stability, degradation products and further to determine the expiration date of the drug product. Samples are always analysed in several replicates for each batch in crucial steps of the manufacturing process, for final medicinal product before it is released and also during the stability studies. HPLC is a method of choice for pharmaceutical QC analyses. However, a huge number of samples to be analysed requires faster, reliable and low-solvent consumption methods leading also to lower cost of the analysis. Therefore, HPLC (high performance liquid chromatography) analyses are often replaced by faster, more efficient and more economical UHPLC (ultra-high performance liquid chromatography) analyses or by other fast LC approaches including monolithic or core-shell columns. Electrophoresis or SIC (sequential injection analysis) are also alternatively able to replace conventional HPLC methods, especially due to their very low solvent consumption and thus reduced analysis cost.

© Charles University, Faculty of Pharmacy in Hradec Králové, Akademika Heyrovského 1203, 500 03 Hradec Králové, Czech Republic
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