SPECTROPHOTOMETRIC ANALYSIS OF KETOCONAZOLE IN OINTMENT ON THE TITANIUM-CONTAINING BASIS

Tifungicide group - ketoconazole was used for the production of an ointment based on the gel «Tizol», called «Ketoconazole». To implement it in medical practice, the aim of the study was established - to develop methods for qualitative and quantitative spectrophotometric analysis of ketoconazole in the soft drug form «Ketoconazole».Material and methods. For the study, the pharmaceutical substance ketoconazole (India), 95% ethyl alcohol, ointment containing 0.1 g of ketoconazole and 9.9 g of Tizol gel, acids and strong bases prepared according to the State Pharmacopoeia of the Russian Federation XIV edition were used. The absorption spectra were studied in the near UV region, using domestic spectrophotometer SF-2000. Statistical processing of the experiment results was performed in accordance with the requirements described in the State Pharmacopoeia of the Russian Federation XIV edition, using a personal computer and MS Office application package.Results. Identification of ketoconazole in the substance and ointment is proposed to be carried out by the optical characteristics of the absorption spectrum of the acid solution of the drug. According to the method of quantitative determination of ketoconazole, spectrophotometric analysis is performed at a wavelength of 241 nm, calculating the drug content according to the equation of the calibration graph. The sensitivity of the method has a value of 0.755 μcg/ml, the relative error is ± 1.42 %.Conclusion. The developed methods of qualitative and quantitative spectrophotometric analysis of ketoconazole in the soft drug form «Ketoconazole» allow to identify the drug and establish its content within acceptable regulatory deviations without prior separation from the titanium-containing base of the ointment.

ketoconazole, tizol, ointment, spectrophotometry, qualitative, quantitative analysis

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