ABOUT THE POSSIBILITY OF CONTAMINATION OF ANALYTICAL SAMPLES DURING QUALITY CONTROL OF MEDICINES AND WORK WITHIN THE SAME LABORATORY ROOM WITH DIFFERENT SUBSTANCES
Authors: Nikolaieva Y.U. , Levin M.G. 
Published: December 2022

The aim of the stady. To determine the concentration of diclofenac sodium in the air of the working area within the same room in order to determine the possible contamination of the sample being analyzed, when simultaneously working with different substances of medicinal products.

Materials and methods. Air sampling was carried out using a TYPHOON-S4 electric aspirator for 30 minutes at a speed of 20 l/min. The test to determine the concentration of diclofenac sodium in air was carried out by concentrating the analytical sample with regard to the microconcentration of the substance by the method of solid-phase extraction, using Oasis MCX 6cc (150 mg) LP Extraction Cartridges, after which desorption was carried out with a solvent - methanol. The obtained samples were analyzed by the method of high-performance liquid chromatography using a Dionex Ultimate 3000 chromatograph with a diode-matrix detector. The sensitivity of the method reaches ng/ml.

The results. As part of the work, a specific, highly sensitive method for determining the concentration of sodium diclofenac in the air was developed and testing was carried out by determining the concentration of sodium diclofenac in the air of the working area during certain analytical operations (pouring, weighing the substance, crushing tablets containing the active pharmaceutical ingredient under analysis, homogenization). The linear dependence of the diclofenac sodium peak area on the concentration of the substance in the solution (0.025-10 μg/ml) has been proven. Based on the obtained data, it was established that the volatile microparticles of diclofenac sodium substance are subject to air deposition, and as a result, a certain amount of this API penetrates into the analyzed samples of other drugs nearby. This fact can lead to obtaining unreliable results during the control of the quality and safety of medicinal products, which can have negative consequences for preserving the health of the population when using medicinal products of inadequate quality. At the same time, the research results show a proportional decrease in the concentration of sodium diclofenac in the air of the working area within one laboratory room as the air aspiration distance from the analytical operation being performed increases. However, at a distance of 0.2 m, the content of sodium diclofenac in the air of the working area exceeds the MPC by two times. These results indicate not only the possible background contamination of the analytical sample during the simultaneous work of several or one operator with different APIs or ready-made medicinal products, but also the possible harm to the analyst's health.

Conclusions. A technique for determining microconcentrations of the active substance in the air of the working area has been developed. It has been found that samples can be easily contaminated with microparticles from other sources if proper precautions are not taken during collection, sample preparation and analysis. Special care should be taken, precautions should be taken, and operating procedures should be developed to minimize the risk of unwanted migration of contaminants in the quality and safety control of medicinal products.