Pharmaceutical industry, high-performance liquid chromatography

Several technology leaps have taken place in separation sciences during the lifetime of the pharmaceutical industry. The development of chromatography at the end of the nineteenth century was the first of these revolutions and its transformation into thin-layer chromatography (TLC) provided the mainstay for quantitative analysis well into the second half of the twentieth century. With the development of gas chromatography (GC) after World War II and high-performance liquid chromatography (HPLC) two decades later, the age of fully instrumented separation science had arrived. 

The molar absorptivity (e) of a known molecule is constant under identical conditions of solvent, concentration and path length, and can be used to quantify the amount of a particular pharmaceutical in a tablet. Such assays form the basis of many quality assurance procedures in the pharmaceutical industry, and have been extensively used by the British Pharmacopoeia (B.P.). More recently, however, high-performance liquid chromatography (HPLC) has replaced UV analysis in many B.P. assays, as most industrial analyses routinely use HPLC. 

High performance liquid chromatography (HPLC) is a common analytical technique used to determine a wide range of organic compounds. Its application has been widespread in industries such as dyes, paints, and pharmaceuticals. More than two thirds of all organic compounds can be analyzed using HPLC methods. Its application in environmental analyses, however, has been relatively recent. Only a limited number of U.S. EPA methods are based on HPLC techniques. 

One standard method approach that appears to have wide application in the pharmaceutical industry is the use of reversed-phase high performance liquid chromatography (HPLC) with a wide solvent gradient program. For example, a linear gradient from 95%... 

Many different products are now purified by chromatographic processes, from the laboratory scale (a few grams) up to the industrial pharmaceutical scale (a few tons per year) or even up to the petrochemical scale (100,000 tons per year). Among the possible technologies, the elution high-performance liquid chromatography (HPLC) technology (sometimes with recycle) has taken a very important part of the small-scale (10 tons per year) market... 

A variety of MS formats are widely accepted and applied in the pharmaceutical industry. The specific MS application is often defined by the sample introduction technique. The pharmaceutical applications highlighted in this article feature two types of sample introduction techniques dynamic and static. Dynamic sample introduction involves the use of high-performance liquid chromatography (HPLC) on-line with MS. The resulting liquid chromatography/mass spectrometry (LC/MS) format provides unique and enabling capabilities for pharmaceutical analysis. The electrospray ionization (ESI) and atmospheric pressure chemical ionization (APCI) modes are the most widely used. Static sample introduction techniques primarily use matrix-assisted laser desorption/ionization (MALDI). ... 

Many of the most important chemical questions in the pharmaceutical industry involve the analysis of complex mixtures. Identification of low-level metabolites and drug substance impurities usually requires high-performance liquid chromatography for the separation of these mixtures or isolation of a compound of interest from a sample matrix. In these analyses, the structural information obtainable for the low-level compounds is limited by the type of detection used. The coupling of HPLC and mass spectrometry has become routine and provides useful molecular weight and fragmentation information, but this is often not enough for complete structure elucidation. 

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