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Drug Development projects

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Introduction :


Drug Development projects can generate hundreds of thousands of compounds that scientist may analyse to characterize structures and identify the impurities. Once they have identified drug target and have run bioassay to understand better how it functions, they can focus their efforts on finding small organic molecules that alter the target functions. To analyze these small entities as well as larger molecules, life scientists increasing relay on methods like HPLC, HPTLC, LC-MS. Liquid chromatography-mass spectrometry (LC-MS) is an analytical technique that couples high resolution chromatographic separation with sensitive and specific mass spectrometric detection. This includes high performance liquid chromatography (HPLC)-MS. It is probably the most powerful technique for pharmaceutical analysis. The major applications of LC-MS in pharmaceutical analysis have been in drug metabolism studies, the analysis and identification of impurities and degradation products in pharmaceuticals and the isolation and characterization of potential drug substances from natural synthetic sources.

LC-MS Method :

LC/MS methods are applicable to a wide range of compounds of pharmaceutical interest, sensitivity, selectivity, speed of analysis, and cost effectiveness. These analytical features have continually improved, resulting in easier to use and more reliable instruments. These improvements were timely and coincided with the aforementioned developments in the pharmaceutical industry. Analytic technique by which chemical substances are identified by sorting gaseous ions by mass using electric and magnetic fields. A mass spectrometer uses electrical means to detect the sorted ions, while a mass spectrograph uses photographic or other non electrical means either device is a mass spectroscope.

Automated injection technique

Automation is a critical demand in modern pharmaceutical analysis and quality control, since strict legislation regarding Good Laboratory

(GLP) and Manufacturing Practice (GMP) require extensive analyses of huge amounts of samples during all stages of the manufacturing process of a pharmaceutical formulation. An automated flow injection determination of some phenothiazine derivatives, based on their

Oxidation with iron (III) in a strongly acidic medium. A flow injection spectro photometric procedure is proposed for determining adrenaline

in pharmaceutical formulations. A simple, rapid and precise reversed phase liquid chromatographic method is developed for simultaneous determination of Atorvastatin, Ezetimibe and Fenofibrate in their ternary mixture of commercial pharmaceutical preparations. Extensive analyses of huge amounts of samples during all stages of the Manufacturing process of a pharmaceutical formulation. Automation is a critical demand in modern pharmaceutical analysis

and quality control, since strict legislation regarding Good Laboratory (GLP) and Manufacturing Practice (GMP) require extensive analyses of huge amounts of samples during all stages of the manufacturing process of a pharmaceutical formulation.

Future trends in drug development :


Pharmaceutical analysis referred to the chemical analysis of drug molecules. However, over the years, modern pharmaceutical analysis has evolved beyond this to encompass combination techniques, high-throughput technologies, chemo metrics, micro dosing studies, miniaturization and nanotechnology. These analytical advances are now being employed in all stages of drug discovery and the focus of this review will be on how these technologies are being employed within this process. With new, improved and evolving technologies, as well as new applications for existing technology, the search for new drugs for the prevention and treatment of human diseases continues. Automated combinatorial chemistry can now synthesize a near-infinite number of compounds. The problem is narrowing down the possibilities to a reasonable subset to synthesize and screen. Metabolic determinations are an integral part of every drug-discovery and drug-development. Recent emphasis has been to increase sample throughput while, at the same time, increase information content within assays. To this end, screening for potential drug–drug interactions, overall metabolic stability and metabolite profiles are used early in discovery to select compounds for development. It is a novel liquid chromatography and mass spectrometry as the preferred analytical tool, and potential solutions to maximize output.
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