Quantitative Determination of Ivermectin in Polymer Microspheres

Разработка и регистрация лекарственных средств

O. I. Rybchenko¹  A. V. Meleshko¹  S. A. Kedik²  Yu. M. Domnina²  V. V. Suslov²  A. I. Mogaibo² 

[1] JSC Institute of Pharmaceutical Technologies;Federal State Budget Educational Institution of Higher Education "MIREA – Russian Technological University";

关键词: ivermectin;    polymer microparticles;    high-performance liquid chromatography;    validation;   

DOI  :  10.33380/2305-2066-2022-11-1-90-97

来源: DOAJ

【 摘 要 】

Introduction. Ivermectin is known as a veterinary agent with a wide spectrum of action against endo-and exoparasites of farm animals, which makes its use promising. Therefore, the possibility of creating prolonged parenteral dosage forms using polymer biodegradable carriers is currently being investigated. To carry out their quality control, a method of quantitative determination of the active substance is necessary. Most of the previously proposed methods are characterized by time-consuming sample preparation, complex composition of the mobile phase or a long analysis time, therefore, during the development of an injectable prolonged preparation of ivermectin based on polycaprolactone microparticles, a new method for the quantitative determination of ivermectin was proposed, which is simple and suitable for use in production.Aim. Development of a method for the quantitative determination of ivermectin in the composition of polycaprolactone microparticles and its validation.Materials and methods. Microparticles with ivermectin were used as the object of the study. The method of quantitative determination of ivermectin in the test sample was developed on a high-performance liquid chromatograph Dionex UltiMate 3000 (Thermo Fisher Scientific, USA), equipped with a diode-matrix detector.Results and discussion. In this paper, various conditions for the quantitative determination of ivermectin in the composition of polymer microparticles are studied. Based on the obtained data and results, a method has been developed that has optimal sample preparation and analysis conditions.Conclusion. As a result of the development, the conditions for the analysis were selected, which allow us to evaluate the quantitative content of ivermectin in the sample. The method was validated for the parameters specificity, analytical area, linearity, trueness, repeatability, intermediate precision.

【 授权许可】

Unknown