Aim. To develop the composition and technology for obtaining a dietary supplement “Cachinol” with the antioxidant activity in the form of granules used in the polycystic ovary syndrome. Materials and methods. To achieve the goal, physical, physicochemical, pharmacotechnological and statistical research methods, as well as generally accepted research methods of the State Pharmacopoeia of Ukraine (SPhU) 2.0 were used in the work. Results and discussion. The rational dosage form is granules. The green tea leaf extract and myo-inositol were chosen as the active pharmaceutical ingredients of granules. For 3 batches of granules, the following parameters were determined: the fractional composition ranging from 13.2 to 17.9 % for 3-2 mm, from 45.3 to 56.2 % for 2-1 mm, from 20.1 to 26.1 % for 1-0.5 mm, from 8.1-12.4 for 0.5-0.25 mm, from 2.95-4.6 % for < 0.25 mm; the moisture content of granules ranging from 2.80-3.10 %; the bulk density – from 0.49 to 0.52 g/cm3, the tapped density – from 0.54 to 0.58 g/cm3; the flowability was in the range of 8.00-8.25 g/s; the angle of repose – from 30 to 33°; disintegration – from 41 to 45 s. Conclusions. The flowchart for obtaining granules in industrial conditions has been developed. The technological process for obtaining granules consists of 8 technological stages. The studies of the technological parameters of granules have been performed in accordance with the requirements of the SPhU 2.0. It has been found that the granules developed meet the requirements of the SPhU 2.0 and can be recommended for further research.

The study of validation parameters of the quantitative determination method of riboflavin by specific absorbance and their assessment have been conducted in order to standardize procedures for analysis by the specific absorbance and the stage-by-stage control of correctness of the results obtained during the validation experiment. According to the requirements of the State Pharmacopoeia of Ukraine (SPhU) the qualification of the spectrophotometer has been performed. The control of the cells (δ dif ≤ 0.002), absorbance accuracy, absorbance convergence with removing the cells (RSD 0 0.0007% ≤ 0.25%), as well as the study of the limit of stray light (absorbance of the solution at the wavelength of 198 nm is 2.56 ≥ 2.0, which meets the requirements of SphU) have been carried out. Characteristics and acceptance criteria of the assay method for riboflavin such as the nominal concentration of the substance in solution by the method, the nominal absorbance and requirements for its minimum value, the maximum uncertainty of the analysis procedure have been theoretically calculated. The linearity parameter has been studied at 9 points. The linear dependence plot has been constructed in the normalized coordinates. The values of b, s b , a, s a , RSD 0 and r calculated comply with the requirements to parameters of the linear dependence. When studying the parameter of accuracy the systematic error is δ = 0.72%, which meets δ ≤ 1.00%. According to the results of the convergence study the relative confidence interval Δ As = 0.83% does not exceed the critical value for convergence of the results Δ As = 0.96%. The validation parameters of the method meet the requirements of the SPhU and are characterized by qualitative analytical indicators.

Aim. To develop а new simple non-enzymatic method for the determination of acetylcholine (ACh) by the chemiluminescent reaction of luminol under conditions of the enzymatic hydrolysis of acetylcholine (pH 8.5).Experimental part. The method proposed is based on the perhydrolysis reaction of ACh by the excess ofhydrogen peroxide with the formation of peracetic acid. The latter was further determined by the activation effect of the luminol chemiluminescent oxidation reaction in the presence of hydrogen peroxide. The analytical signal was the summary luminescence (Σ) registered within certain time.Results and discussion. The pH range of the analytically applicable system was from 8.2 to 8.5. The effect of ACh + H2O2 incubation period on the reaction progress was also studied. The increase of the incubation period enhanced the sensitivity of the method (the limit of detection (LOD)), but because of practical reasons (especially the detection speed) and practical experience the incubation period was set to 30 min. The linear dependence was observed in the acetylcholine chloride concentration range of (0.8 – 2.8) × 10-4 mol/L. While determining acetylcholine chloride in the concentration range of (1.1 – 2.2) × 10-4 mol/L the relative standard deviation (RSD) did notexceed 3 % ((X – μ) × 100 %/μ = –0.5…+0.5 %). The Limit of Quantitation (LOQ, 10S) was 7.7 × 10-5 mol/L.Conclusions. A new non-enzymatic kinetic method for the chemiluminescent determination of ACh in aqueous solutions and the pharmaceutical formulation Acetylcholinchlorid Injeel® has been proposed. This method is simple, fast, inexpensive, and thus appropriate for the routine ACh quality control in the laboratories of hospitals, pharmaceutical industries and research institutions.Key words: acetylcholine; chemiluminescence method