Abstract
The study of dissolution profiles is important as a cheap and easy supplement to bioequivalence research, and as a variation to such studies. This method is not outlined in the State Pharmacopoeia of Ukraine for the doxycycline capsules. Therefore, according to the current requirements, it was necessary to verify the procedure recommended by the US Pharmacopeia to confirm that this laboratory test will be reproduced correctly, and to use it in our further studies.The aim of our research was to verify the Dissolution test analytical procedure for doxycycline hyclate capsules, recommended by the US Pharmacopoeia.Methods. Capsules of doxycycline hyclate 100 mg and set of mineral waters were taken as study objects. A standard sample of doxycycline was used for preparation the comparison solutions. All reagents and test specimens meet the requirements of the SPhU. The experimental data were obtained at the same time in a standardized procedure. For this purpose, 9 points were studied within the range 55-135 % with a step of 10 %. The obtained results were processed statistically in accordance with the requirements of the SPhU.Results. The conducted prediction showed that the total uncertainty of the results of the methodic is 1.04 %, which does not exceed the critical value (3.0 %). To determine the specificity, the effect of placebo was investigated. The calculation showed that the overall effect of placebo on the total absorption of the drug is non-significant (0.51 % ≤ 0.96 %). Also, the method is linear in the range of concentrations from 55 % to 135 %. The systematic error of the results meets the recommended criteria.Conclusions. The analysis of model mixtures of doxycycline hyclate showed the correctness of the investigated method
Highlights
IntroductionUkraine continues to update national quality standards to European ones. The State Pharmacopoeia of Ukraine (SPhU) is harmonized with the European Pharmacopoeia, yet the European Pharmacopoeia does not produce monographs for the dosage forms
Nowadays, Ukraine continues to update national quality standards to European ones
The studied method of the "Dissolution" test for capsules of doxycycline hyclate was taken from the US Pharmacopoeia [6]
Summary
Ukraine continues to update national quality standards to European ones. The State Pharmacopoeia of Ukraine (SPhU) is harmonized with the European Pharmacopoeia, yet the European Pharmacopoeia does not produce monographs for the dosage forms. The studied method of the "Dissolution" test for capsules of doxycycline hyclate was taken from the US Pharmacopoeia [6]. To confirm the possibility of using the dissolution test procedure for doxycycline hyclate capsules, results obtained during the experimental study were compared with the analytical characteristics of the dissolution test such as: accuracy; precision: repeatability, intermediate precision; specificity; linearity. The study of the linear dependence of the absorbance on concentration was performed on 9 model mixtures in the range of the method application, as recommended by the SPhU, for assay of the active substance in the dosage forms in the range from 55 % to 135 % with a step of 10 % [12]. Results of the study of linear dependence on the doxycycline hyclate model mixture
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