
Development of standardization methods of gel with sapropel extract and their validation
Curr Issues Pharm Med Sci., Vol. 36, No. 1, 27-32
Oksana Strus1*
, Ivan Revyatskyy2
, Serhii Holota3,4
, Sergey Gushcha5
1 Department of Drug Technology and Biopharmaceutics, Danylo Halytsky Lviv National Medical University, Ukraine
2 Department of Management and Economy of Pharmacy, Medicine Technology and Pharmacoeconomics, Postgraduate Faculty, Danylo Halytsky Lviv National Medical University, Ukraine
3 Department of Organic Chemistry and Pharmacy, Lesya Ukrainka Volyn National University, Ukraine
4 Department of Organic, Bioorganic and Pharmaceutical Chemistry, Danylo Halytsky Lviv National Medical University, Ukraine
5 Department of Fundamental Research, State Institution "Ukrainian Research Institute of Medical Rehabilitation and Resort Therapy of Ministry of Health of Ukraine, Odessa, Ukraine
© 2023 Author(s). This is an open access article distributed under the Creative Commons Attribution-NonComercial-No Derivs licence (http://creativecommons.org/licenses/by-nc-nd/3.0/)
Abstract
Humic acids (HA) are important natural compounds that are characterized by a wide range of biological activity and therapeutic impact on different pathological processes. Sapropels are natural healing resources that contain a large amount of HA. The pharma-ceutical market of Ukraine needs domestic drugs with dermatotropic action based on natural compounds that have a combined antibacterial, wound healing and anti-inflammatory activity, as well low toxicity.
The aims of the research: standardization of the gel under the conditional name "Saprogel" for use in medicine as a wound-healing and anti-inflammatory agent, development of methods for identification and quantification, as well as their validation.
A linear dependence between the concentration of the total mass fraction of HA on the mass of the sample of aqueous sapropel extract (ASE) with a correlation coefficient of 0.9985 (≥0.9981) was observed, while the angular coefficient of linear dependence (b) was found to be 1.02, with the free member of linear dependence (a) being – 1.66≤2.60. The obtained results show that the method is precise because the value of the relative confidence interval is less than the critical value for the convergence of the results: Δ%=1.27≤1.60 and the criterion of the insignificance of systematic error: δ=0.51. As a result of the quantitative analysis, we found that the total mass fraction of HA in the gel samples from the wind farm is 1.302%.
Keywords
humic acids, validation, identification, gel, quantification, aqueous sapropel extract.
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