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Application of the capillary electrophoresis and liquid chromatographic in microemulsion methods for quantification of water and fat-soluble vitamins: cross validation

Grant number: 09/17467-3
Support type:Regular Research Grants
Duration: August 01, 2010 - January 31, 2013
Field of knowledge:Health Sciences - Pharmacy - Medicines Analysis and Control
Principal Investigator:María Segunda Aurora Prado
Grantee:María Segunda Aurora Prado
Home Institution: Faculdade de Ciências Farmacêuticas (FCF). Universidade de São Paulo (USP). São Paulo , SP, Brazil

Abstract

Vitamins are essential organic compounds required for the normal functioning of cellular metabolism. It is known that the human needs 13 water- and fat-soluble vitamins and their absence can lead to illness. Vitamins are presents in the foods, beverages (fortified juice beverages as vitamins and nectars) and in a variety of pharmaceuticals (multivitaminics). The production of drugs compounds containing vitamins must be valued by rigorous procedures quality control to guarantee their effectiveness and safety. For this reason, there are used high sensitivity, specificity and reproducibility methods for determination of vitaminic compounds. Most of the vitamins are determined by high performance liquid chromatography (HPLC) and HPLC-Mass spectrometry (MS) methods in biological fluids, pharmaceuticals and foods. Recently, capillary electrophoresis (CE), different kinds of CE and CE-MS have been widely used for determination of vitamins in pharmaceuticals and biological fluids. The aim of the present project is to develop microemulsion systems using microemulsion liquid chromatography (MELC) water/oil and/or oil/water and microemulsion electrokinetic chromatography (MEEKC) water/oil techniques, as new kinds of CE and HPLC, respectively to simultaneously separation and quantification vitamins water- and fat-soluble vitamins in pharmaceuticals and validate the obtained results by both of them methods. At the present, there is any work for this for this purpose. The drug substances will be characterized through physic-chemical tests. The development of MEEKC and MELC methods will done through experimental design. The methods validation will be done according The United States Pharmacopeia, USP 31th and International Conference on Harmonisation (ICH) protocols. The valued parameters will be linearity, range, detection limit, quantitation limit, specificity, precision, accuracy, and robustness. The validated methods will be applied to commercial samples vitamins (obtained from drug stories and/or pharmaceutical industries of São Paulo city) for their drug purity determination; it will be done by triplicate. The obtained results by MEEKC and MELC methods will be compared by t and F tests. The project broaches a current and relevant topic to Pharmaceutical area, especially to physic-chemical quality control to guarantee the pharmaceutical products effectiveness and safety. As consequence of the project we hope to form students of graduation and post graduation and the publication. (AU)