Nowadays, many different kinds of chromatography techniques, such as thin-layer chromatography (TLC), paper chromatography, and liquid chromatography (e.g., HPLC, UPLC, and preparative HPLC), supercritical fluid chromatography, and gas chromatography (GC)) have been designed and utilized for the separation and purification of pharmaceutical drugs. Keeping in mind the various fields where this technique has been used, this chapter focuses on the use of chromatography in pharmaceuticals for separating the drug (API) mixture in particular. Invention of chromatography made the jobs of organic chemist and the whole industry relying on them especially pharma industry easier. Chromatography is invented by Mikhail Semenovich Tswettin 1903 during his research on plant pigments such as chlorophylls, xanthophylls, and carotenoids which got extended for analyzing organic molecules of different kinds especially pharmaceutical from the year 1920.
The constituents of a mixture dissolved in solvent get separated gradiently according to their affinities to the stationary phase with the help of mobile phase one after another. It is well known that chromatography is a laboratory technique used for separation and quantification of complex organic mixtures which cannot be separated effectively by other purification techniques. And it mostly plays a vital role in the development and manufacture of pharmaceuticals drugs. The analytical method development is a process of proving the developed analytical method is suitable for its intended use for the quantitative estimation of the targeted analyte present in pharmaceutical drugs.
A suitable analytical method is developed only after evaluating the major and critical separation parameters of chromatography (examples for UPLC/HPLC are selection of diluent, wavelength, detector, stationary phase, column temperature, flow rate, solvent system, elution mode, and injection volume, etc.). Mainly, the versatile techniques of ultra−/high-performance liquid chromatography (UPLC/HPLC) are in use for the analysis of assay and organic impurities/related substances/degradation products of a drug substance or drug product or intermediate or raw material of pharmaceuticals. This chapter aims to explain the key parameters of analytical method development using the chromatography techniques which are used for the identification, separation, purification, and quantitative estimation of complex mixtures of organic compounds.
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