New, simple and express determination of lamotrigine in tablets by using diazole red 2J

Authors

DOI:

https://doi.org/10.15587/2519-4852.2022.253542

Keywords:

spectrophotometry, analysis, lamotrigine, diazole red 2J, validation studies, Ukrainian Pharmacopeia

Abstract

Epilepsy is considered one of the most common chronic neurological diseases among humans. Lamotrigine is an effective new-generation anticonvulsant, which is widely introduced to the pharmaceutical market by various drug manufacturers. That is why the urgent aim for pharmaceutical analysis is developing of high precision, valid, accessible and quantitative methods for lamotrigine in pharmaceuticals.

The aim of the work is to study the optimal conditions for the reaction between lamotrigine and diazole red 2J, to define the coefficients of stoichiometric relationships in the “pharmaceutical substance – reagent” system and to develop a valid, sensitive and easy-to-follow technique for the quantitative determination of lamotrigine in pharmaceutical forms.

Material and methods. As reagent and solvent, diazole red 2J of AR grade and acetone of AR grade were used. Analytical equipment: Specord 200 spectrophotometer, ABT-120-5DM electronic scales, Elmasonic E 60H ultrasonic bath and measuring glassware of A class.

Results. A new spectrophotometric method for the quantitative determination of lamotrigine in four pharmaceutical formulations based on interaction with diazole red 2J in acetone medium has been developed. The proposed method is valid according to such validation characteristics as linearity, precision, intra-laboratory precision, accuracy, application range and robustness. The subordination to Behr's law is in the range of concentrations of 2.20–3.36 mg/100 ml. The LOD and LOQ values based on the values of the calibration line were 0.00450 % and 0.0138 % respectively. It was found that the studied coloured solutions are stable for at least 60 min and fluctuations in the amount of added red diazole 2J solution within ±10 % do not significantly affect the value of optical density. The coefficients of stoichiometric ratios between the components of the “lamotrigine – diazole red 2J” reaction mixture were defined by three methods and are 1:1. The predicted complete uncertainty of the results of analysis for quantitative determination of lamotrigine in the pharmaceutical form (2.2 %) does not exceed the maximum allowable uncertainty for the technique (3.2 %) and meets the SPhU requirements.

Conclusions. According to the experimental data, the technique can be correctly reproduced and it is suitable for using in laboratories of the State Inspection for Quality Control of Medicines and QCD of the chemicopharmaceutical enterprises

Author Biographies

Kateryna Miedviedieva, Zaporizhzhia State Medical University

PhD, Associate Professor

Department of Analytical Chemistry

Svitlana Vasyuk, Zaporizhzhia State Medical University

Doctor of Pharmaceutical Sciences, Professor

Department of Analytical Chemistry

Alla Korzhova, Zaporizhzhia State Medical University

PhD, Associate Professor

Department of Analytical Chemistry

Ivan Pavljuk, Zaporizhzhia Research Forensic Center of the Ministry of Internal Affairs of Ukraine

PhD, Senior Forensic Expert

References

  1. British Pharmacopoeia Commission (2016). London: British Pharmacopoeia, TSO.
  2. Sabença, R., Bicker, J., Silva, R., Carona, A., Silva, A., Santana, I. et. al. (2021). Development and application of an HPLC-DAD technique for human plasma concentration monitoring of perampanel and lamotrigine in drug-resistant epileptic patients. Journal of Chromatography B, 1162, 122491. doi: http://doi.org/10.1016/j.jchromb.2020.122491
  3. Abou-Taleb, N. H., El-Sherbiny, D. T., El-Enany, N. M., El-Subbagh, H. I. (2022). A new grey relational analysis application in analytical chemistry: Natural deep eutectic solvent as a green extractant for HPLC determination of lamotrigine in plasma. Microchemical Journal, 172. doi: http://doi.org/10.1016/j.microc.2021.106918
  4. Croci, D., Salmaggi, A., de Grazia, U., Bernardi, G. (2001). New High-Performance Liquid Chromatographic Method for Plasma/Serum Analysis of Lamotrigine. Therapeutic Drug Monitoring, 23 (6), 665–668. doi: http://doi.org/10.1097/00007691-200112000-00012
  5. Torra, M., Rodamilans, M., Arroyo, S., Corbella, J. (2000). Optimized Procedure for Lamotrigine Analysis in Serum by High-Performance Liquid Chromatography Without Interferences From Other Frequently Coadministered Anticonvulsants. Therapeutic Drug Monitoring, 22 (5), 621–625. doi: http://doi.org/10.1097/00007691-200010000-00019
  6. Ventura, S., Rodrigues, M., Pousinho, S., Falcão, A., Alves, G. (2016). An easy-to-use liquid chromatography assay for the analysis of lamotrigine in rat plasma and brain samples using microextraction by packed sorbent: Application to a pharmacokinetic study. Journal of Chromatography B, 1035, 67–75. doi: http://doi.org/10.1016/j.jchromb.2016.09.032
  7. Abou-Taleb, N. H., El-Sherbiny, D. T., El-Enany, N. M., El-Subbagh, H. I. (2020). Multiobjective optimization of microemulsion- thin layer chromatography with image processing as analytical platform for determination of drugs in plasma using desirability functions. Journal of Chromatography A, 1619. doi: http://doi.org/10.1016/j.chroma.2020.460945
  8. Nikolaou, P., Papoutsis, I., Dona, A., Spiliopoulou, C., Athanaselis, S. (2015). Development and validation of a GC/MS method for the simultaneous determination of levetiracetam and lamotrigine in whole blood. Journal of Pharmaceutical and Biomedical Analysis, 102, 25–32. doi: http://doi.org/10.1016/j.jpba.2014.08.034
  9. Theurillat, R., Kuhn, M., Thormann, W. (2002). Therapeutic drug monitoring of lamotrigine using capillary electrophoresis. Journal of Chromatography A, 979 (1-2), 353–368. doi: http://doi.org/10.1016/s0021-9673(02)01257-8
  10. Greiner-Sosanko, E., Giannoutsos, S., Lower, D. R., Virji, M. A., Krasowski, M. D. (2007). Drug Monitoring: Simultaneous Analysis of Lamotrigine, Oxcarbazepine, 10-Hydroxycarbazepine, and Zonisamide by HPLC-UV and a Rapid GC Method Using a Nitrogen-Phosphorus Detector for Levetiracetam. Journal of Chromatographic Science, 45 (9), 616–622. doi: http://doi.org/10.1093/chromsci/45.9.616
  11. Abou-Taleb, N. H., El-Enany, N. M., El-Sherbiny, D. T., El-Subbagh, H. I. (2021). Spider diagram and Analytical GREEnness metric approach for assessing the greenness of quantitative 1H-NMR determination of lamotrigine: Taguchi method based optimization. Chemometrics and Intelligent Laboratory Systems, 209. doi: http://doi.org/10.1016/j.chemolab.2020.104198
  12. Rajendraprasad, N., Basavaiah, K. (2012). Simple and Sensitive Spectrophotmetric Determination of Lamotrigine in Pure Form and in Dosage Forms. Pharmaceutica Analytica Acta, 3 (9). doi: http://doi.org/10.4172/2153-2435.1000188
  13. Biscaia, I., Todeschini, V., de Meira, R., Nogueira, C., Bernardi, L., de Oliveira, P. (2020). Development of a First-Order Derivative UV Spectrophotometric Method for the Assay and Solubility Evaluation of Lamotrigine and Nicotinamide Cocrystals. Journal of the Brazilian Chemical Society, 31 (12), 2561–2568. doi: http://doi.org/10.21577/0103-5053.20200134
  14. Heidari, H., Mammostafaei, C. (2021). Spectrophotometric determination of lamotrigine in plasma samples: Ultrasound-assisted emulsification-microextraction based on a hydrophobic deep eutectic solvent followed by back-extraction. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy, 247. doi: http://doi.org/10.1016/j.saa.2020.119098
  15. Rajendraprasad, N., Basavaiah, K., Vinay, K. B. (2010). Sensitive spectrophotometric determination of lamotrigine in bulk drug and pharmaceutical formulations using bromocresol green. Eclética Química, 35 (1), 55–66. doi: http://doi.org/10.1590/s0100-46702010000100007
  16. Rajendraprasad, N., Basavaiah, K., Vinay, K. B. (2010). Micro and nanogram determination of lamotrigine in pharmaceuticals by visible spectrophotometry using bromophenol blue. Indian Journal of Chemical Technology, 17 (3), 220–228.
  17. Jayanna, B. K., Devaraj, T. D. (2016). Spectrophotometric Estimation of Lamotrigine in Tablets. Indian Journal of Pharmaceutical Sciences, 78 (5), 657–662. doi: http://doi.org/10.4172/pharmaceutical-sciences.1000165
  18. Bulatov, M. I., Kalinkin, I. P. (1986). Prakticheskoe rukovodstvo po fotometricheskim metodam analiza. Leningrad: Himiya, 432.
  19. Derzhavna Farmakopeia Ukrainy. Vol. 1 (2015). Kharkiv: Derzhavne pidpryiemstvo «Ukrainskyi naukovyi farmakopeinyi tsentr yakosti likarskykh zasobiv», 1128.
  20. Grisodub, A. I. (2016). Standartizovannyye protsedury validatsii metodik kontrolya kachestva lekarstvennykh sredstv. Kharkiv: Derzhavne pidpryiemstvo «Ukrainskyi naukovyi farmakopeinyi tsentr yakosti likarskykh zasobiv», 396.

Downloads

Published

2022-02-28

How to Cite

Miedviedieva, K., Vasyuk, S., Korzhova, A., & Pavljuk, I. (2022). New, simple and express determination of lamotrigine in tablets by using diazole red 2J. ScienceRise: Pharmaceutical Science, (1(35), 44–51. https://doi.org/10.15587/2519-4852.2022.253542

Issue

No. 1(35) (2022)

Section

Pharmaceutical Science

License

Copyright (c) 2022 Kateryna Miedviedieva, Svitlana Vasyuk, Alla Korzhova, Ivan Pavljuk

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Our journal abides by the Creative Commons CC BY copyright rights and permissions for open access journals.