Abstract

The aim of this study is to develop a universal, rapid and affordable method for the identification of dydrogesterone, troxerutin, and ademetionine in drugs by multisensor digital colorimetry using a unique two-dimensional code. The developed approach can be applied to rapid detection of counterfeit drugs at the preliminary stage of the analysis (before using more expensive specialized equipment). Materials and methods. To implement the proposed approach, the substances of dydrogesterone (“Abbott Biologicals B.V.”, Netherlands), troxerutin (JSC “Interfarma”, Prague, Czech Republic) and ademetionine (LLC “Farmamed”, Moscow, Russia) , troxerutin capsules 300 mg (LLC “Pranafarm”, Samara, Russia), lyophilisate for an intravenous solution and the intramuscular administration “Heptral” ® (ademetionine) 400 mg (“Abbott Laboratories”, GMBH, Germany), tablets “Duphaston” ® (dydrogesterone) 10 mg (“Abbott Healthcare Products B.V.”, Netherlands), were used. A multisensor colorimetry method has been implemented using the following set of 8 sensors (C 1 -C 8 ): an intact solution – a 96% (v/v) aqueous ethanol solution – C 1 ; 1 mM alcoholic solution of anthraquinone green (CAS#4403-90-1) – C 2 ; a 0.2% aqueous solution of 3-methylbenzothiazolinone hydrazone (CAS#1128-67-2) – C 3 ; a 0.2% methyl orange aqueous solution (CAS#547-58-0) – C 4 ; a 1 mM alcoholic solution of sulforhodamine B (CAS#3520-42-1) – C 5 ; a 1 mM alcoholic solution of 1-hydroxypyrene (CAS#5315-79-7) – C 6 ; 1 mM alcoholic solution of allura red AC (CAS#25956-17-6) – C 7 ; a 1 mM aqueous solution of iron (III) chloride – C 8 . Transparent flat-bottomed polypropylene plates with 96 cells, with a cell volume of 350 µl (Thermo Fischer Scientific, USA, cat. No. 430341) were used as a base for the chip. For obtaining raster images, an Epson Perfection 1670 office flatbed scanner (CCD-matrix) with a removable cover was used. The obtained digital images of the cells were processed using the ImageJ software (Wayne Rasband, National Institutes of Health, USA; http://imagej.nih.gov/ij) with a 24-bit RGB color model (8 bits per channel). Results. The adequacy of the developed approach was confirmed by the analysis of the above-listed drugs. It has been shown that the results obtained have no statistically significant differences from the values determined by the spectrophotometric method. Conclusion. The possibility of using multisensor digital colorimetry for pharmaceutical analysis has been shown. The developed methods for the identification of the active substances can serve as a good supplement to the more expensive traditional methods.

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