DETERMINATION OF HYDAZEPAM IN THE AIR OF THE WORKING AREA OF PHARMACEUTICAL ENTERPRISES

Abstract

Gidazepam is the international non-proprietary name of the active pharmaceutical ingredient, on the basis of which drugs are manufactured that are used as daytime tranquilizers for neurotic, psychopathic asthenia, sleep disorders, etc. In the conditions of pharmaceutical production, hidazepam can enter the air of the working area in the form of an aerosol and negatively affect the health of workers. The aim of the work was to develop a technique for determining gidazepam in the air of the working area, which can be used to control the maximum permissible concentration of the substance. Materials and methods. The methodology was developed using the requirements of DSTU EN 482:2016. The physicochemical properties of the compound were studied on the basis of literature data, the method and optimal conditions for measuring the substance were established experimentally. Calculation the working characteristics of the method and the uncertainty of the measurement result was carried out in accordance with the requirements and recommendations of Eurachem and the sanitary legislation of Ukraine. Research results. Gidazepam by its chemical structure belongs to benzodiazepine derivatives, by its aggregate state it is a crystalline powder, which determines its aggregate state in the air, namely, an aerosol. Hidazepam was determined by the spectrophotometric method at λ = 283 nm, using a solution of hydrochloric acid with a molar concentration of 0.1 mol/dm3 as a solvent. Air sampling was carried out by aspiration of an aerosol of the substance with capture on filter with a volumetric flow rate of 10.0 dm3/ min for 10.0 minutes. The established working characteristics of the technique: working range (mg/m3) ‒ 0.05‒0.20; extended measurement uncertainty (U, %) ‒ 17.5; precision (r, %) ‒ 6.6; indicator of intermediate precision (rf, %) ‒ 9.0; reproducibility index (R, %) ‒ 16.0; stability indicator of the grading characteristic (Kgr, %) ‒ 6.0. Conclusions. A technique for determining gidazepam in the air of the working area has been developed, which meets the requirements for reference methods used to control state medical and sanitary standards. A spectrophotometric method was used, which is based on measuring the intrinsic light absorption of the substance solution in the UV region of the spectrum at λ = 283 nm. The established operating characteristics of the technique provide the appropriate level of accuracy and can be used to assess the reliability of measurement results.