Specifications development for "Karbatril" codenamed tablets

Authors

  • L. I. Kucherenko Zaporizhzhia State Medical University,
  • A. R. Nimenko Zaporizhzhia State Medical University,
  • O. O. Portna Zaporizhzhia State Medical University,

DOI:

https://doi.org/10.14739/2409-2932.2017.2.103759

Keywords:

carbamazepine, thiotriazoline, «Karbatril», specification

Abstract

Introduction. According to current legislation of Ukraine the specifications of tablets include the following indicators: description, identification, average weight, disintegration and assay.

The aim of the study. The development of specifications and project of quality control methods for "Karbatril" codenamed tablets.

Materials and methods. During the study we analyzed 6 series of tablets "Karbatril." For the description, identification, determination of the average mass, disintegration, active ingredients quantify of "Karbatril" codenamed tablets we used appropriate methods and instruments.

Results and discussion. Tablets "Karbatril" were analyzed for the following parameters:

- Overview - Tablets white or nearly white;

- Average weight - during the study the average weight of 6 series of obtained tablets ranged from 339,0 mg to 369,9 mg according to SPU from 337,0 mg to 373,0 mg;

- Disintegration – according to SPU the disintegration for tablet without shell shall not exceed 15 min. Analyzed tablets disintegrated in the period from 5 to 10 minutes;

- Identification and quantification of the active ingredients of tablets were conducted using modified HPLC methods. During the identification obtained chromatograms show compliance with SPU. In quantitative determination of the active ingredients content in "Karbatril" codenamed tablets we found carbamazepine from 148.18 mg to 150.19 mg, thiotriazoline - from 98.93 mg to 99.71 mg. This data is consistent to SPU which regulates content of carbamazepine - 150 mg ± 7,5%, thiotriazoline - 100 mg ± 10%.

Conclusions. This study has developed specification for "Karbatril" codenamed tablets and also methods of HPLC qualitative and quantitative determination of active ingredients. In the specification the following parameters are included: description, identification, average weight, disintegration and assay. The study drafted quality control methods which are planned to be later offered to the manufacturer.

References

Kucherenko, L. I., Bielenichev, I. F., Mamchur, V. I., Opryshko, V. I., Portna, O. O., & Nimenko, H. R. (2015) Pidvyshchennia efektyvnosti likuvannia epilepsii [Improved treatment of epilepsy. Innovation newsletter in health care]. Kyiv. [in Ukrainian].

Agarwal, A., Nallella, K. P., Allamaneni, S. S., & Said, T. M. (2004) Role of antioxidants in treatment of male infertility : an overview of the literature. Reprod Biomed. Online., 8, 616–627. doi: 10.1016/S1472-6483(10)61641-0.•

Mazur, I. A., Voloshin, N. A., Chekman, I. S., Zimenkovskij, B. S., & Stec, V. P. (2005) Tiotriazolin [Thiotriazoline]. Zaporozh´e, L´vov. [in Russian].

Avakyan, G. N., Ryzhova, M. V., Badalyan, O. L., Burd, S. G., & Stojko, M. I. (2005). Primenenie antioksidanta gruppy 3-oksipiridina v kombinirovannoj patogeneticheskoj terapii bol´nykh parcial´nymi e´pilepsiyami [The use of antioxidant group 3-hydroxypyridine in combination pathogenetic therapy of patients with partial epilepsy]. Zhurnal nevrologii i psikhiatrii im. S.S. Korsakova, 6, 21–25. [in Russian].

Derzhavne pidpryiemstvo «Naukovo-ekspertnyi farmakopeinyi tsentr» (2015) Derzhavna farmakopeia Ukrainy [State Pharmacopoeia of Ukraine]. Kharkiv. [in Ukrainian].

Derzhavne pidpryiemstvo «Naukovo-ekspertnyi farmakopeinyi tsentr» (2015) Derzhavna Farmakopeia Ukrainy. Addition 1 [State Pharmacopoeia of Ukraine]. Kharkiv. [in Ukrainian].

Georgievskij, V. P. (Ed) (2012) Analiticheskaya khimiya v sozdanii, standartizacii i kontrole kachestva lekarstvennykh sredstv [Analytical chemistry in creating standardization and quality control of medicine s]. (Vol. 2 Khromatograficheskie metody), (P. 474). Kharkiv. [in Russian].

Kucherenko, L. I., Nimenko, Н. R., Vashchenko, O. V., & Vashchenko, V. V. (2016). Shchodo sumisnoho vyznachennia karbamazepinu ta tiotryazolinu v modelnii sumishi metodom VERKh. Povidomlennia 1: pidbir fazy dlia sumisnoho vyznachennia karbamazepinu ta tiotryazolinu u modelnoi sumishi metodom VERKh [Carbamazepine and thiotriazoline simultaneous definition in model mixture by HPLC. Message 1: phase selection for the simultaneous determination of carbamazepine and thiotriazolin in model mixture by high performance liquid chromatography]. Farmatsevtychnyi chasopys, 1, 54–58. [in Ukrainian].

Kucherenko, L. I., Nimenko, Н. R., Vashchenko, O. V., & Vashchenko, V. V. (2016). Shchodo sumisnoho vyznachennia karbamazepinu ta tiotryazolinu v modelnii sumishi metodom VERKh. Povidomlennia 2: vybir fazy dlia sumisnoho vyznachennia karbamazepinu ta tiotryazolinu v modelnii sumishi metodom VERKh (hradiientne eliuiuvannia) [Carbamazepine and thiotriazoline simultaneous definition in model mixture by HPLC. Message 2: phase selection for the simultaneous determination of carbamazepine and thiotriazolin in model mixture by high performance liquid chromatography (gradient elution)]. Farmakom, 2, 27–32. [in Ukrainian].

Kucherenko, L., Nimenko, A., & Portnaya, E. (2016). Razrabotka metodov kontrolya kachestva smesi karbamazepina i tiotriazolina [Development of quality control methods of a mixture consisting of carbamazepine thiotriazoline]. Recept, 6, 683–689. [in Russian].

Downloads

How to Cite

1.
Kucherenko LI, Nimenko AR, Portna OO. Specifications development for "Karbatril" codenamed tablets. Current issues in pharmacy and medicine: science and practice [Internet]. 2017Jun.21 [cited 2024Apr.20];(2). Available from: http://pharmed.zsmu.edu.ua/article/view/103759

Issue

No. 2 (2017)

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)