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

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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].

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.14];(2). Available from: http://pharmed.zsmu.edu.ua/article/view/103759

Issue

Section

Analysis and standardization of biologycally active substances and dosage forms