DEVELOPMENT OF NEW CRITERIA TO IDENTIFICATION AND QUANTITATIVE DETERMINATION OF THE COMPONENTS OF MULTICOMPONENT SYSTEMS BY CHROMATOGRAPHIC METHODS

Currently a great number of drugs, which are complex multicomponent mixtures of natural and synthetic substances, are registered at the pharmaceutical market of Ukraine. While identifying multicomponent drugs by high performance liquid chromatography (HPLC) all components of mixtures are usually analyzed separately by their retention times; for each of the components the corresponding reference standard (RS) is used. To control the quality of multicomponent drugs we offer to use the ratio of peak areas of the substances to be analyzed obtained from the chromatogram of multicomponent mixtures with further normalization of these ratios. The ratios are suggested to be calculated by one of the drug components – a supporting agent. Testing of the method suggested has been carried out using the drug Ortofen-Zdorovye forte, coated tablets. Such dyes as Azorubine and Ponceau 4R is in the composition of the drug coating. To analyze these dyes the specific analytical wavelength – 500 nm has been chosen; Azorubine has been chosen as a supporting agent. Application of the given approach to determination of the dyes in the composition of the drug allows to complete the requirements of normative documents on the drug with the value of the ratio of the dyes peaks, and it is an additional guarantee of the drug quality. This new approach to identification and quantitative determination of the components of multicomponent systems by chromatographic methods allows to tighten regulations over the quality of drugs and fix the quantitative composition of the drug in rather narrow range. The application of the approach developed for the drug analysis allows also to simplify the pharmaceutical analysis significantly and make it cheaper.