Development and validation of the «dissolution» test for riboxine tablets
DOI:
https://doi.org/10.15587/2313-8416.2016.64504Keywords:
Riboxine, dissolution, UV-Vis absorption spectroscopy, tabletsAbstract
Under conditions of the pharmaceutical industry intensive development and variety of oral drugs, the improvement of specialists’ knowledge about remedies of this category and processes taking place in human’s organism at their absorption remains relevant. To increase the bioavailability of drugs and to reduce adverse pharmacological effects, the dissolution test has been implemented for tablet dosage forms.
Aim. The aim of our research was to develop and to validate the dissolution test methods for tablets, containing Riboxine as an active ingredient, which has metabolic, antihypoxic and antiarrhythmic effect, and recently is produced by Ukrainian pharmaceutical manufacturers.
Methods. The dissolution test was carried out using ERWEKA DT 806 HH instrument for determination of tablets solubility. Analytical research were carried out by the absorption spectroscopy method using Specord 205 («Analytik Jena AG», Germany) spectrometer with the use of OHAUS AP 250D («Ohaus Corporation», USA) electronic laboratory scales and type A laboratory glassware.
Results. As a result of research, the dissolution agent (water), its volume, the active ingredient concentration, and the time of the test (45 minutes) has been chosen. It was suggested to determine the amount of Riboxine passed into the solution by the method of UV-Vis absorption spectroscopy at wavelength 249 nm using standard method.
Validation parameters according to the SPhU requirements, i.e. specificity, linearity, precision (convergence), accuracy, and range of application were studied. It was determined that validation parameters of the method didn’t exceed the critical error (3,0 %).
Conclusion. In result of performed experimental research the spectroscopy method for Riboxine quantitative determination after pharmaco-technological dissolution tests was developed and validated. Dissolution agent, its volume, dissolution time and the amount of tablets for determination was suggested
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Copyright (c) 2016 Микола Володимирович Росада, Наталія Юріївна Бевз, Вікторія Акопівна Георгіянц
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