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Analysis and standardization of some new medical preparations with the application of spectral and chromatographic methods

Author: Şepeli Diana
Degree:doctor of chemistry
Speciality: 02.00.02 - Analytical chemistry
Scientific adviser: Mihail Revenco
doctor habilitat, professor, Moldova State University
Scientific council:


The thesis was presented on the 10 October, 2008
Approved by NCAA on the 22 January, 2009


Adobe PDF document0.40 Mb / in romanian
Adobe PDF document0.34 Mb / in romanian


CZU 543.63 + 543.42 + 543.54+ 615.4:54

Adobe PDF document 7.54 Mb / in russian
185 pages


chromatography, spectrophotometry, molonylamides of p-aminobenzoic acid, tincture of fennel, anethole, cineole, carotenoids, flavonoides, sclareol, fennel, clary sage, pot marigold


The thesis is presented as a manuscript.

This dissertation is devoted to the elaboration of original methods of quantitative determination of the principal active substances of the new preparations obtained on the base of local plant raw materials (a clary sage (CS) (Salvia sclarea L.) and a fennel (Foeniculum v

ulgare Mill.)), as well as synthetic products with use of (thin layer and gasliquid) chromatography and spectrophotometry. Spectrophotometric methods of analysis have been elaborated for the first time for quantitative determination of anethole in the fennel tincture and preparations Fenglicol and Fencarin, sum of carotenoids in Fencarin, sum of flavonoides (quercetin, kaempferol, quercitrin, yuglanin, rungiozid, aphzelin) in preparations Salvit-1 and Salmus from clary sage. The determinated conditions for separation of the components in Fenglicol with application of gas-liquid chromatography (GLC) have permitted to elaborate a quantitative method of simultaneous analysis of anethole and cineole using the calibration curves.

The results of analytical researches by the elaborated methods of analysis using the thin layer chromatography (TLC), extraction and spectrophotometry have demonstrated that the clary sage preparations have differed in content of biologically active substances (BAS).

The new preparation Salvit-1 has exceeded approximately twice the official preparation Salmus by the content of flavonoides and volatile oils. CS steams have contained the same BAS as Salvit-1 and it was possible to use them for production of this preparation. For standardization of the CS preparations additionally methods of quantitative analysis of extractive, reducing and oxidable substances have been proposed. The method of quantitative determination of sclareol with application of chromatography with gravimetrical finalization has been elaborated.

For the control of purity of the preparation Mabipan during the synthesis, storage and sterilization of their pharmaceutical forms, the TLC technique has been used. A chromatospectrophotometrical method of quantitative analysis of Mabipan in the presence of impurities has been elaborated.

Usefulness of the method of analysis for standardization of the investigated preparations and accuracy of the results have been proved by statistical treatment data as well as methods of model solutions with use of standard samples. In addition it has been elaborated reactions of BAS identification of the new plant preparations and some other quality parameters required in composition of Temporary Pharmacopoeia Monographs (TPM).

On the basis of proposed analytical methods it has been composed projects of TPM for plant preparations, carried out investigation of their technological reproducibility and determined expiration data. Seven patents for invention have been gained under the materials of the presented thesis. Key words: chromatography, spectrophotometry, molonylamides of p-aminobenzoic acid, tincture of fennel, anethole, cineole, carotenoids, flavonoides, sclareol, fennel, clary sage, pot marigold