Stage control of tablets manufacturing

Authors

  • L. I. Kucherenko
  • O. V. Khromylyova
  • Z. B. Moryak
  • G. I. Tkachenko
  • E. V. Vashchenko

DOI:

https://doi.org/10.14739/2409-2932.2014.2.26134

Keywords:

Isoniazid, Thiotriazolin, Tablets, Chromatography, Tuberculosis

Abstract

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.

Conclusion.

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.

 

 

References

Georgievskij, G. V. (2011) Razrabotka kompleksa fiziko-khimicheskikh metodik, obespechivayushhikh sozdanie i kontrol' kachestva original'nykh otechestvennykh preparatov, proizvodnykh 1,2,4 – triazola [The development of the complex of physicochemical techniques providing creation and quality control of original domestic drugs, derivatives of 1,2,4-triazole]. Zaporozhskij medicinskij zhurnal, 1(13), 58–69. [in Ukrainian].

(2004) Derzhavna Farmakopeia Ukrainy [State Pharmacopeia of Ukraine]. Kharkov: RIREG. [in Ukrainian].

Il`nickaya, L. I. (2007) Sostoyanie i sovremennye podkhody k uluchsheniyu ftiziopul'monologicheskoj pomoshhi razlichnym vozrastnym gruppam naseleniya v usloviyakh vysokoj zabolevaemosti tuberkulezom [The state and modern approaches to the improving of phthisiopulmonological help to different age groups of population in the conditions of high tuberculosis prevalence]. Problemy tuberkulyoza i boleznej legkikh, 5, 12–14. [in Russian].

Кucherenko, L. I., & Khromylyova, О. V. (2013) Vybir dopomizhnykh rechovyn z metoyu otrymannia tabletok izoniazydu z tioyriazolinom metodom volohoi hranuliatsii [The choice of adjuvants with the aim of making of tablets with isoniazid and thiotriazolin by damp granulation method]. Farmacevtychnyi chasopys, 4(29), 83–87. [in Ukrainian].

Кucherenko, L. I., Khromylyova, О. V., Vashhenko, V. V., & Moryak, Z. B. (2013) Podbor optimal'nykh uslovij analiza smesi izoniazida i tiotriazolina metodom vysoko e`ffektivnoj zhidkostnoj khromatografii [Choice of optimal conditions of isoniazid and thiotriazolin mixture analysis by high-performance liquid chromatography method]. Sovremennaya farmacevtika: potencial rosta v dolgosrochnoj perspektive», Proceedings of the International Conference. (pp. 15–21). Kirov [in Russian].

Mazur, I. A., Voloshyn, N. A., & Chekman, I. S. (2005) Tiotriazolin [Thiotriazolin]. Zaporozhye ; Lvov: Nautilus. [in Ukrainian].

Feshchenko, Yu. I., & Melnyk, V. M. (2007) Kontrol za tuberkulozom v umovakh Adaptovanoi DOTS-stratehii [Control of tuberculosis in conditions of adapted ДОТС-strategy]. Kyiv. [in Ukrainian].

Shatc, V. D. (1998) Vysokoe`ffektivnaya zhidkostnaya khromatografiya [High-performance liquid chromatography]. Riga: Zinatne. [in Latvia].

Adamovics, J. A. (1997) Chromatographic analysis of pharmaceuticals. New York: Marsel Dekker.

(2002) Global tuberculosis control: WHO Report 2002. Geneva.

Downloads

How to Cite

1.
Kucherenko LI, Khromylyova OV, Moryak ZB, Tkachenko GI, Vashchenko EV. Stage control of tablets manufacturing. Current issues in pharmacy and medicine: science and practice [Internet]. 2014Jul.8 [cited 2024Dec.24];(2). Available from: http://pharmed.zsmu.edu.ua/article/view/26134

Issue

No. 2 (2014)

Section

Analysis and standardization of biologycally active substances and dosage forms

License

Authors who publish with this journal agree to the following terms:

    1. Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.     Лицензия Creative Commons
    2. Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
    3. Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access)