DEVELOPMENT AND UNIFICATION OF A THIN-LAYER CHROMATOGRAPHIC METHOD FOR THE ANALYSIS OF PHENSULKAL IN SOFT DOSAGE FORMS.

Abstract

In order to study the improvement and unification of quality control of phensulkal in soft dosage forms (suppositories, gels), the technic of thin layer chromatography (TLC) was used. On the basis of the experiments, the solvent selection, elution conditions, the frequency of extraction of the active substance from the dosage form and the composition of the extraction fluid, the volume of the sample, the type of plate for the identification of phensulkal by the TLC technic were substantiated. In the course of carrying out a qualitative analysis of phensulkal in suppositories according to the developed method, the Rf values of the studied samples were consistent with the chromatographic mobility of working standard (WS). No additional patches were found, therefore, the interaction products between the medication components are not formed, phensulkal is compatible with the ingredients of the base material and does not undergo destruction during the manufacturing process. On chromatograms obtained during the research of extracts from placebo suppositories, it was found that in experimental samples of dosage forms, unidentified patches were not found, which indicates the correct choice of the conditions for the extraction of the active factor. The developed TLC technic was used to determine the quality indicators of vaginal suppositories and gels with phensulkal and introduced into new draft regulatory documents.

Keywords:

standardization, phensulkal, thin layer chromatography, specificity, sensitivity, reproducibility.