Stage control of tablets manufacturing
Keywords:Isoniazid, Thiotriazolin, Tablets, Chromatography, Tuberculosis
Today in Ukraine tuberculosis is the wide-spread infectious disease causing the death in most cases; about 700 thousand persons are suffering from it. In Ukraine epidemic of tuberculosis is progressing and spreading. In spite of all protective measures three inhabitants of our country contract tuberculosis per hour, every hour one patient dies and in common about 1.5% of the population is ill with tuberculosis. Isoniazid is antituberculous drug of the first line and it is the most effective one. Chemotherapy of tuberculosis requests long-lasting administration of antituberculous drugs that causes high risk of side effects. To prevent or lessen side effects of antituberculous medicines antioxidants use in complex therapy is perspective. Fulfilled investigations showed efficacy of combining two medical substances – isoniazid andthiotriazolin – in one dosage form.
Objective.The aim of our investigation is working out the methods of standardization, in particularquantitative determination of isoniazid andthiotriazolin content in tablet mass by high-performance liquid chromatography (HPLC).
Materials and Methods.During in-process investigations combined tableted remedy containing isoniazid andthiotriazolin and proper amount of adjuvants has been developed (it contains active substances isoniazid – 0.2 g,thiotriazolin – 0.05 g and adjuvants up to the 0.4 g of the tablet). During stage control of tablets manufacturingspecial attention is paid to the control of tablet mass quality. Especially it concerns quantitative determination of active substances in it. More and more attention is paid to modern physical-chemical methods of standardization in up-to-date analysis of drug products, such as ultraviolet spectrometry, high-performance liquid chromatography (HPLC) etc. In previous scientific investigations we proved the possibility of standardization of active substances artificial compound by HPLC method and optimal conditions of analysis performing have been defined.
Results and discussion.While developing HPLC method we checked five series of tablet mass. According to the analysis results it has been revealed that all series met the requirements of State pharmacopeia of Ukraine for the content of active substances. Isoniazid content is within the values of 0,2005 g -0,2117g, and thiotriazolin - 0,0487g - 0,0550 g. It is the reason to state that in the result of our investigations we have worked out the method of tablet mass analysis which is accurate and reproducible. It gives the right to recommend it for use in stage control of “Triathiosid” tablets quality.
During our investigations on the development of analysis methods of tablet mass of isoniazid and thiotriazolinsensitive, accurate,objective,valid, reproducible HPLC method has been worked out which is planned to be used in stage control of “Triathiosid” tablets quality.
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