Development and validation of a method for the quantitative determination of marbofloxacin in the substance and drug "Marbotim" in the form of a solution for injection
https://doi.org/10.52419/issn2072-2419.2025.3.114
Abstract
The aim of this work was to develop and validate a method for the quantitative determination of marbofloxacin in the substance and the medicinal product "Marbotim" in the form of an injection solution using highperformance liquid chromatography. The following tasks were solved in the course of the work: to develop methods for the quantitative determination of marbofloxacin in the substance and medicinal products based on it, to validate the method for the quantitative determination of marbofloxacin in the substance and in the preparation "Marbotim" in the form of an injection solution. The quantitative content of marbofloxacin was determined using high-performance liquid chromatography according to OFS.1.2.1.2.0005 or FEAEC 2.1.2.28 [4]. The work used the analytical standard sample of marbofloxacin series G1297125 (DR. EHRENSTORFER) with the content of the active substance of 99.28%, acetonitrile (Alpha Chemika, India), trifluoroacetic acid (Central Drug House, India), glacial acetic acid (SigmaAldrich, USA) and ultrapurified water obtained using the Rephile Genie U device that produces ultrapure water (type I water) and reverse osmosis water (type III water) (China). Validation was carried out according to OFS.1.1.0012. A 0.1% (vol.) solution of acetic acid was used as a solvent. The standard solution of marbofloxacin, test solutions of marbofloxacin substance and the medicinal product "Marbotim" were prepared using a solvent (0.1% acetic acid solution) and with a final concentration of marbofloxacin - 16 μg / ml. Based on the results of testing for the parameters: specificity, linearity, convergence, intralaboratory precision, accuracy, analytical range, robustness, the methods for the quantitative determination of marbofloxacin in the substance and the medicinal product "Marbotim" in the form of an injection solution were assigned the status "Validated".
About the Authors
K. E. Bobkova
Apicenna LLC
Russian Federation
Russian Federation
senior analytical chemist
Y. E. Kuznetsov
St. Petersburg State University of Veterinary Medicine
Russian Federation
Russian Federation
doctor of veterinary medicine sciences, Associate Professor
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Review
For citations:
Bobkova K.E., Kuznetsov Y.E. Development and validation of a method for the quantitative determination of marbofloxacin in the substance and drug "Marbotim" in the form of a solution for injection. International Journal of Veterinary Medicine. 2025;(3):114-124. (In Russ.) https://doi.org/10.52419/issn2072-2419.2025.3.114
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