USING THE METHOD OF ATOMIC ABSORPTION SPECTROMETRY WITH ELECTROTHERMAL ATOMIZATION FOR ANALYSIS OF THIOMERSAL IN IMMUNOBIOLOGICAL MEDICINES

Issue: 
7
Year: 
2015

A.N. Mironov
Dr.Sc. (Med.), Professor, Scientific Center of Expertise of Medical Application (Moscow)
I.V. Sakaeva
Ph.D. (Pharm.), Deputy General Director, Scientific Center of Expertise of Medical Application (Moscow)
T.M. Kargina
Ph.D. (Biol.), Leading Research Scientist, Center Pharmacopoeia and International Cooperation,
Department of State Pharmacopeia and Pharmacopeia analysis (CFMS, GFFA),
Scientific Center of Expertise of Medical Application (Moscow)
E-mail: Topaz-313@mail.ru
E.I. Sakanyan
Dr.Sc. (Pharm.), Professor, Director of the Center Pharmacopoeia and International Cooperation (CFMS),
Scientific Center of Expertise of Medical Application (Moscow)

In Russia, the analysis of thiomersal (thimerosal) in immunobiological medicines (IM) is carried out by the colorimetric method. The colorimetric method is quite long and time-consuming, requires a large amount of reagents and safety studies performed since thimerosal – is a mercury-containing organic compound. Indicators of repeatability and reproducibility of the analysis performed by the colorimetric method is not always satisfying the demands, which leads to additional analyze. The target was composed in the development of a method corresponding to the level and requirements of modern laboratory analysis. In connection with the intended purpose, developed atomic-absorption with electro thermal atomization method for the determination of thiomersal in IМ. Set validation method performance: linearity – in the range of 0.25 to 1.00 μg/ ml, correctness – is satisfactory and did not exceed 4.00 %. In assessing the reproducibility and repeatability of methods – the coefficient of variation does not exceed 8.26 %. Specificity techniques confirmed the correctness of the results obtained, including in the presence of sorbent. The results of the validation method for quantitative determination of thiomersal in IМ using atomic absorption with electro thermal atomization confirm its adequacy and can recommend it for inclusion in the Russian State Pharmacopoeia, as well as for use in research, control and analytical laboratories, companies and institutions involved in development, production, quality control and marketing of medicines containing thiomersal. Atоmic-absorption method with electro thermal atomization can be recommended for the control of trace amounts of thiomersal, or to confirm its presence in the adsorbed medicines as one the most specific, sensitive end well played.

Keywords: 
Keywords: thiomersal
atomic absorption method with electrothermal atomization
series sorbed domestic and foreign medicines.