Chromatography is a laboratory technique for the separation of mixtures of chemical substances into their components. The separations which are complicated are achieved rapidly and efficiently by chromatography techniques. Chromatography may be analytical or preparative, analytical chromatography is normally done with smaller amounts of material to establish the presence or measures the relative proportions of analytes in the mixture and preparative chromatography is to separate the components of the mixture and in the form of purification.
Chromatography has wide applications and has a significant role in fields like Pharmaceuticals, Chemical Industry, Food and beverage Industry, Environmental analysis, Forensic science, and Petroleum Industry.
Chromatographic techniques which are widely used by the pharmaceutical industry are mainly High-performance liquid chromatography (HPLC), Thin Layer Chromatography (TLC), and Gas chromatography, due to the wide range of capabilities of chromatography it is used at various stages during R&D development, analytical development, stability studies, manufacturing process; such as during the stages of the synthesis of intermediates to know its purity and impurities. In pharmaceuticals, chromatographic techniques are used to ensure the high quality of drugs.
Chromatographic methods are often used for the quantitative and qualitative analysis of raw materials, drug products, drug substances, and compounds in biological fluids. The components monitored also include chiral or achiral drugs, residual solvents, process impurities, excipients degradation products, preservatives, extractable and leachable from the container and closure or manufacturing process and metabolites, etc.
Identification of pharmaceutical substances for the drug substance and drug product, their stability, and bioavailability have become the most important analytical tasks during the process development, discovery, production, quality control, and bioavailability studies.
Chromatography has wide applications and has a significant role in fields such as the Pharmaceuticals and Chemical Industry, Food and beverage Industry, Environmental analysis, Forensic science, and petroleum industry, etc.
Pharmaceuticals applications of chromatographic techniques
In the Pharmaceutical and chemical industry chromatography techniques mainly used are High-performance liquid chromatography (HPLC), Thin Layer Chromatography (TLC), and Gas chromatography to give precise results which are required for the purity of drug substance, drug product, drug stability, separation of chiral compounds, analyzing the purified compounds for traces of impurities, etc. The advantage of HPLC is in elucidating the structures and determining the quantities of impurities in pharmaceutical drug products and drug substances.
Environmental applications: Pollutants biomonitoring, detection of phenolic compounds in drinking water and monitoring air quality, etc.
Forensic applications: Chromatography has unique applications in Forensics like quantification of drugs in biological samples, analysis of textile dyes, identification of steroids in blood, urine, etc. Chromatography is very important for Forensic pathology work.
Food and flavor: Chromatography is used to analyze sugar in fruit juices, separating and analyzing additives, proteins, amino acids, vitamins, quality of soft drinks and water, and preservative analysis. Food products contain a complex mixture of compounds (these compounds when present above the concentration level) that may be naturally occurring, at the manufacturing stage or the harvest stage.
In the Pharmaceutical industry, chromatographic techniques used are High-performance liquid analysis (HPLC), the advantage of HPLC is in elucidating the structures, determining the quantities of impurities and efficient and accurate results, and ensuring high quality of drugs.
Impurities are present in pharmaceutical products or drug substances and need to be identified and characterized by using suitable analytical methods. HPLC is frequently used to determine the assay and impurities in drug substances and drug products.
Chromatography has wide applications and has a significant role in fields like the Pharmaceutical and Chemical Industry, Food and beverage Industry, Environmental analysis, Forensic science, and petroleum Industry, etc.
Chromatography is a laboratory technique used for separating and identifying the components of a mixture based on their physical and chemical properties. In chromatography, the mixture is first dissolved in a mobile phase, which is then passed through a stationary phase. The different components of the mixture interact with the stationary phase to varying degrees, leading to their separation.
- González-González, Mirna; Mayolo-Deloisa, Karla; Rito-Palomares, Marco (1 January 2020), Matte, Allan (ed.), “Chapter 5 – Recent advances in antibody-based monolith chromatography for therapeutic applications”, Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics, Elsevier, pp. 105–116.
- Alternative bioseparation operations: life beyond packed-bed chromatography T.M. Przybycien, N.S. Pujar and L.M. Steele Curr Opin Biotechnol, 15 (5) (2004), pp. 469-478.
- Center for Drug Evaluation and Research (CDER) Reviewer Guidance’ Validation of Chromatographic Methods. 1994, www.fda.gov/media/75643/download.