Article Sidebar

Submitted
December 9, 2021
Accepted
September 19, 2022
Published
December 8, 2022
Download
PDF (Bahasa Indonesia)
Statistic
Read Counter : 559 Download : 774

Downloads

Download data is not yet available.

Main Article Content

Abstract

Clobazam is a drug with the chemical name 7‐chloro‐1‐methyl‐5‐phenyl‐1,5‐benzodiazepine, which is used to treat various types of epilepsy. Clobazam works on the brain and central nervous system to provide a calming effect. To maximize the therapeutic effect and reduce the drug's toxic effect, it is necessary to test to determine the levels in the sample of clobazam that fulfilled requirements. One way to control drugs is to strengthen the capacity and capability of testing by developing reference standards. The more reference standards developed, the more drug samples can be tested. The development of reference standards is aimed at producing the “Baku Pembanding Farmakope Indonesia (BPFI)” which can be used for qualitative and quantitative testing of clobazam samples. This test aims to produce the clobazam “Baku Pembanding Farmakope Indonesia (BPFI)” which fulfilled the characterization and purity requirements as a reference standard. Characterization was achieved by infrared spectroscopy with the wave number results showed aromatic C=C functional groups (1490.97 cm-1), C=O cyclic ketones (1670.35 and 1691.57 cm-1), and C-N amines (1330.88 and 1375.25 cm-1), UV-Vis spectroscopy results showed a wavelength of 230.5 nm, gas chromatography-mass spectroscopy results showed the main ion (m/z) of clobazam was 207 (C13H4NO2); 255.1 (C15H11ClN2); 257.1 (C14H9ClN2O); 258.1 (C14H10ClN2O); and 300 (C15H7ClN2O2), and 1HNMR, 13CNMR, HMQC, and HMBC spectroscopy which showed that the raw material was clobazam. The purity of clobazam was measured using HPLC-DAD and obtained a purity index of 1.0000 and a purity of 99.73% (n=20, SD= 0.01%, RSD=0.01%), and by DSC obtained a purity of 99, 33% and a melting point of 180.55oC. All validation parameters of the HPLC analysis method were specificity/selectivity, system-appropriate test (RSD = 0.05%), linearity (R = 0.9997) with a range of 0.015% to 0.045%, accuracy 0.19%, and precision 0, 01% have fulfilled the requirements. The characterization results of clobazam and determination of purity value ​​can be used as “Baku Pembanding Farmakope Indonesia (BPFI)” and used in qualitative and quantitative tests by all Indonesia FDA provincial offices and stakeholder ABG (Academic, Business, government).

Keywords

clobazam characterization Baku Pembanding Farmakope Indonesia (BPFI) klobazam, karakterisasi, kemurnian, Baku Pembanding Farmakope Indonesia (BPFI)

Article Details

How to Cite
Kristiana, E., Br. Tampubolon , W. S., & Supardiati E. S, A. (2022). Characterization and Purity Test of Clobazam by High Performance Liquid Chromatography as a Comparison Standard for Indonesian Pharmacopoeia. Eruditio : Indonesia Journal of Food and Drug Safety, 2(2), 33–43. https://doi.org/10.54384/eruditio.v2i2.122
Download Citation
Endnote/Zotero/Mendeley (RIS)
BibTeX

References

  1. Badan Pengawas Obat dan Makanan. (2021). Pedoman Pengembangan Baku Pembanding. 2021, pp. 1-14.
  2. Bala, R., Khanna, S., & Pawar, P. (2014). Design Optimization and In vitro-In Vivo Evaluation of Orally Dissolving Strips of Clobazam. Journal of Drug Delivery, 2014, 1-15. https://doi.org/10.1155/2014/392783
  3. Bala, R., Khanna, S., & Pawar, P. K. (2013). Formulation and optimization of fast dissolving intraoral drug delivery system for clobazam using response surface methodology. Journal of Advanced Pharmaceutical Technology & Research, 4(3), 151-159.
  4. British Pharmacopoeia Commision Laboratory. (2016). British Pharmacopoeia. London: Medicine and Healthcare products Regulatory Agency.
  5. Culbert, P. A., & Johnson, B. D. (2004). Handbook of Isolation and Characterization of Impurities in Pharmaceuticals (Vol. 5). Connecticut, USA: Pfizer Global Research and Development.
  6. Gauthier, A. C., & Mattson, R. H. (2015). Clobazam: a safe, efficacious, and newly rediscovered therapeutic for epilepsy. CNS Neurosci Therapeutics, 21(7), 543-548.
  7. Kumar, N., Devineni, S. R., Dubey, S. K., & Kumar, P. (2017). Potential impurities of anxiolytic drug, clobazam: Identification, synthesis and characterization using HPLC, LC-ESI/MSn and NMR. Journal of Pharmaceutical and Biomedical Analysis, 1-41.
  8. Leontiev, D. A., Volovyk, N. V., Bevz, O. V., Vashchenko, O. V., & Gryzodub, O. I. (2018). Characterization of a reference standard for qualification of differential scanning calorimetry intended for purity determination in certification of pharmaceutical reference standards. Journal of Pharmaceutical Sciences and Research, 10(11), 2709-2714.
  9. Panitia Penyusun FI VI. (2020). Farmakope Indonesia Edisi VI. Jakarta: Kementerian Kesehatan Republik Indonesia.
  10. Pratiwi, R. A., & Nandiyanto, A. B. (2022). How to Read and Interpret UV-VIS Spectrophotometric Results in Determining the Structure of Chemical Compounds. Indonesian Journal of Educational Research and Technology, 2(1), 1-20.
  11. Riahi, S., Bagherzadeh, K., Davarkhah, N., Ganjali, M. R., & Norouzi, P. (2011). Spectrophotometric and Chemometric Studies on the Simultaneous Determination of Two Benzodiazepines in Human Plasma. Materials Science and Engineering C, 31(5), 992-996.
  12. The Royal Pharmaceutical Society of Great Britain. (2004). Clarckes Analysis of Drugs and Poisons. London: the Pharmaceutical Press.
  13. Tolbert, D., & Larsen, F. (2018). A Comprehensive Overview of the Clinical Pharmacokinetics of Clobazam. The Journal of Clinical Pharmacology, 00(0), 1-13.