FIELD: chemistry.
SUBSTANCE: invention relates to the field of analytical chemistry, in particular, to methods for qualitative and quantitative determination of the active substance in finished dosage forms and to means of analysing water-soluble medicinal products using giant Raman scattering spectroscopy, and can be used to assess the quality of medicinal products. The method for qualitative and quantitative determination of a biologically active substance in water-soluble medicinal products consists in recording the GRS spectrum of the aliquot of the solution of the product in a solution of stabilised nanoparticles, comparing the resulting spectrum with the GRS spectrum of a reference sample, and further quantifying the content of the active substance based on the calibration curve previously constructed in the "relative intensity—concentration" coordinates, wherein prior to spectral measurements, an activating additive is additionally introduced into the analysed solution of stabilised nanoparticles with an aliquot of the medicinal product in order to increase the intensity of GRS spectra, simultaneously taken and used as an internal standard in the subsequent quantification of the active substance.
EFFECT: possibility of determining the presence of impurity compounds and the content of the active substance in water-soluble medicinal products at a high speed and sensitivity without preliminary stages of separation and concentration.
5 cl, 3 dwg
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Authors
Dates
2022-06-23—Published
2021-05-04—Filed