METHOD DEVELOPMENT AND VALIDATION OF PHOTOMETRIC DETERMINATION OF IRON IN HEMOSTATIC TOOL
Abstract
The article presents data on the development of a technique of photometric determination of ferric chloride (III) as a hemostatic tool, through the formation of salicylates iron. The developed method was validated for following validation characteristics: specificity, linearity, accuracy. The results of the study the main validation characteristics of the method meet the acceptance criteria. The technique is intended for definition of iron in the painted solutions of medicines in the range of 0,04-0,07 g/ml. Relative error of measurement of 0,83%.
About the Authors
Yu. N. Barsukova
Urals State Medical University of the Ministry of Healthcare of the Russian Federation
Russian Federation
Russian Federation
O. A. Melnikova
Urals State Medical University of the Ministry of Healthcare of the Russian Federation
Russian Federation
Russian Federation
M. Yu. Melnikov
Urals State Medical University of the Ministry of Healthcare of the Russian Federation
Russian Federation
Russian Federation
References
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2. Государственная фармакопея СССР: Вып. 2. Общие методы анализа. Лекарственное растительное сырье. МЗ СССР. 11-е изд., доп. - М.: Медицина, 1990. 399 с.
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4. ICH Harmonized Tripartite Guidelines. ICH Q2B «Validation of Analytical Procedures: Methodology». ICH: Geneva, 1997.
Review
For citations:
Barsukova Yu.N., Melnikova O.A., Melnikov M.Yu. METHOD DEVELOPMENT AND VALIDATION OF PHOTOMETRIC DETERMINATION OF IRON IN HEMOSTATIC TOOL. Drug development & registration. 2017;(2):140-145. (In Russ.)
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