DEVELOPMENT OF A TECHNIQUE FOR THE QUANTITATIVE DETERMINATION OF AMLODIPINE BESYLATE IN AIR BY SPECTROPHOTOMETRY

UDC 543.422.3:613.6:661.12

Krymskaya Tat’yana Petrovna – Head of the Chromatographic Research Laboratory. Research Institute of Hygiene, Toxicology, Epidemiology, Virology and Microbiology (8 Akademicheskaya str., 220012, Minsk, Republic of Belarus). E-mail: chromatographic@rspch.by

Chebotkova Dar’ya Viktorovna – Junior Researcher, the Chromatographic Research Laboratory. Research Institute of Hygiene, Toxicology, Epidemiology, Virology and Microbiology (8 Akademicheskaya str., 220012, Minsk, Republic of Belarus). E-mail: chromatographic@rspch.by

Lamotkin Sergey Aleksandrovich – PhD (Chemistry), Assistant Professor, the Department of PhysicalChemical Methods of Product Certification. Belarusian State Technological University (13a Sverdlova str., 220006, Minsk, Republic of Belarus). Е-mail: jossby@rambler.ru

DOI: https://doi.org/ 10.52065/2520-2669-2025-289-10.

Key words: amlodipine besylate, spectrophotometry, working area air, calcium channel antagonist.

For citation: Krymskaya T. P., Chebotkova D. V., Lamotkin S. A. Development of a technique for the quantitative determination of amlodipine besylate in air by spectrophotometry. Proceedings of BSTU, issue 2, Chemical Engineering, Biotechnologies, Geoecology, 2025, no. 1 (289), pp. 80–86 (In Russian). DOI: 10.52065/2520-2669-2025-289-10.

Abstract

A simple, accurate and precise spectrophotometric method for assessing the mass concentration of amlodipine besylate in the air of pharmaceutical enterprises has been developed. The measurement technique is intended for use by bodies and institutions implementing state sanitary supervision and control over labor safety during production of amlodipine besylate-based drugs. This pharmaceutical substance is produced in the form of drugs such as “Amlodipine” (manufacturer SOOO “Lekpharm”, Belarus), “Amlodipine” (manufacturer “MaxPharma Baltija”, Lithuania), “Cardilopin” (manufacturer “Egis”, Hungry), “Norvask” (manufacturer “Pfizer”, USA), “Stamlo” (manufacturer “Dr. Reddy’s”, India) and etc. The substance belongs to the 1st hazard class, the maximum permissible concentration is 0.10 mg/m3. Control of the pharmaceutical substance amlodipine besylate in the air of the working area should ensure the determination of a concentration of at least 0.05 mg/m3. The method is based on concentrating amlodipine besylate from the air onto AFA-VP filters, extracting it from the filters with methanol, concentrating the extract by completely removing methanol, dissolving the dry residue with methanol and subsequent quantitative determination by spectrophotometry at a wavelength of 360 nm in quartz cuvettes with a layer thickness of 1 cm. The range of measured concentrations of amlodipine besylate in the air of the working area is from 0.05 to 1.20 mg/m3, with sampling of the air volume depending on the expected concentration of the substance being determined in the air of the working area. The following metrological characteristics of the determination method were established: repeatability limit r = 13%, intermediate precision limit RI(TO) = 24%, expanded uncertainty U = 16% with a confidence probability of P = 0.95 and a coverage factor of k = 2.

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