Fast and simple spectrophotometric method for quantitative determination of mometasone furoate in a single dose (single actuation) of its nasal spray was developed and validated. This method is based on the spectrophotometric analysis of turbid solution of a single spray in 20 mL isopropanol at 220–310 nm. We further show applicability of this method for analysis of large number of single sprays for the dosing homogeneity. It is based on a new approach to the development of spectrophotometric quantitative determination methods for drug products and possibly other objects, allowing measurements to be carried out on sufficiently turbid test solutions. The proposed approach is not a variant of the derivative spectrophotometry and can replace the methods of derivative spectrophotometry in cases where: derivative of analyte spectrum is not intense enough; derivative of the spectrum of the matrix (turbidity and remaining components of the product) is significant when compared with the derivative of the analyte.

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.

Background: Secondary to increased development of generic nonsteroidal anti-inflammatory drugs (NSAIDs), there is a lack of simple and inexpensive ways of pilot detection of differences between the batches of generic drugs and the original ones. Objectives: To determine the peculiarities of the use of generic NSAIDs in routine practice through a pilot survey of dentists and to conduct a pilot comparative analysis of generic and original NSAIDs containing nimesulide granules using optical microscopy. Methods: The first part of the study included a pilot survey Convenience sampling of 192 dentists to study the use of generic NSAIDs in their routine practice. The second part included the use of a pilot optical microscopy of nimesulide particles isolated from four drugs: original drug (NA) and generic ones (NB, NC, ND). Results: In the questionnaires, dentists pointed to a 68.7% lower clinical efficacy and a 62.6% higher percentage of side effects of generic NSAIDs compared to the original ones. Based on the results of pilot optical microscopy, a statically significant difference in the size distribution of the drug substance particles in all generic nimesulide granules was determined as follows: NB (χ 2 : 15.15; p < 0.01); NC (χ 2 : 11.09; p < 0.05); ND (χ 2 : 1625.34; p < 0.001) compared with the original drug NA. Conclusions: A pilot survey of dentists showed that doctors noted the practical difference in the effects of the original and generic NSAIDs. A significant difference in the size of nimesulide particles and their distribution in generic drugs NB, NC, ND compared to the original NA suggests a possible difference in bioavailability and bioequivalence.