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APPROACH OF THE STATE PHARMACOPEIA OF UKRAINE TO ANALYTICAL PROCEDURES VALIDATION ON THE EXAMPLE OF CHLORIDE IONS ASSAY IN PERITONEAL DIALYSIS SOLUTIONS

100%
Hudz N., Leontiev D., Wieczorek P. P.
Acta Poloniae Pharmaceutica - Drug Research
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2019
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vol. 76
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issue 4
635-643
EN
The objective of this study was to develop and validate an alternative analytical procedure for the total chloride assay in solutions for peritoneal dialysis (PD). The proposed analytical procedure was validated according to the requirements of the International Conference on Harmonization guideline: Topic ICH Q2(R1) and the approach of the State Pharmacopeia of Ukraine (SPU). The analytical procedure was specific. The linearity of the procedure was evaluated in the concentration range of 76 to 114 mmol/L of chloride ions (80-120 % of the stated content 95 mmol/L) with the regression equation y=1.0029•X-0.2263 and a correlation coefficient of 0.9989. The y-intercept of the regression line did not exceed the maximum permissible value of 2.6. The residual standard deviation (s0=0.65) of the calibration curve met the requirement for max s0 (0.84). The mean recovery was found as 100.07%±0.62 %. The precision study also showed a low value of one-sided 95% confidence limit (∆Z=1.15%) that did not exceed the critical value of 1.6%. The accuracy study also showed that the systematic error had not differed statistically from zero. The developed analytical procedure was also found to be robust and reproducible as contents differences were less 1.6%. The reproducibility studies were conducted with different samples of the same laboratory-made PD solutions in different days and laboratories. The performed studies indicated that the developed analytical procedure is simple, fast and cost-efficient, specific, linear, precise, accurate, and robust. The presented approach could be also applied to the validation of other assay analytical procedures.
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ANALYTICAL PROCEDURE ELABORATION OF TOTAL FLAVONOID CONTENT DETERMINATION AND ANTIMICROBIAL ACTIVITY OF BEE BREAD EXTRACTS

76%
Hudz N., Yezerska O., Grygorieva O., Brindza J., Felsöciová S., Kačániová M., Wieczorek P. P.
Acta Poloniae Pharmaceutica - Drug Research
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2019
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vol. 76
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issue 3
439-452
EN
SSixteen ethanolic extracts were obtained from seven different bee bread samples. The total flavonoid content in the extracts was determined by aluminium-chloride method and was in the range of 8.3 mg/L±6.24% to 195.3 mg/L±1.35% and 28.8 mg/L±19.33% to 603.3 mg/L±4.64% with reference to quercetin and rutin, respectively. The relative standard deviations (RSD) for parallel measurements for the calibration curves of quercetin dehydrate and rutin trihydrate were in the range of 0.51% to 9.39% and 5.02% to 19.91%, respectively. The RSD for parallel measurements for the extracts with reference to quercetin dihydrate and rutin trihydrate were in the range of 0.23% to 11.64% and 4.64% 19.33%, respectively. The total flavonoid content mainly depended on a ratio of bee bread to 50% ethanol and technology of obtaining bee bread. The significant differences between results were statistically confirmed. The best antibacterial activity of bee bread extracts was found against Bacillus cereus CCM 2010, Clostridium perfringens CCM 4435, and Staphylococcus aureus subsp. aureus CCM 4223. The activity of the bee bread extracts against Gram negative bacteria, Aspergillus and Penicillium genera was lower with moderate anticandidal activity. The obtained results indicated that it was very important to employ extracts with a high content of bee bread in 50% ethanol (1:5, 1:10). According to the results of this study, bee bread is a product which is rich in flavonoids and with good antibacterial activity against Gram positive bacteria and can be considered as a raw material for development of diet supplements and antimicrobial medicinal products
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