Development and validation of a method for simultaneous quantitative determination of albendazole and praziquantel in coated tablets “AP-helmin”

Authors

DOI:

https://doi.org/10.15587/2519-4852.2024.290350

Keywords:

validation, liquid chromatography, quantitative analysis, albendazole, praziquantel, coated tablets

Abstract

Adapting modern methods of quantitative analysis of active substances in their joint content in the dosage form and validating them is an integral process of pharmaceutical development. We have developed a drug in the form of coated tablets for the treatment of helminthiases of the digestive system in adults. A feature of this drug is the composition of the API of albendazole and praziquantel in a ratio of 1:4.

The aim of this research is to develop methodology for quantitative analysis of both substances by the method of liquid chromatography, determination of their possible mutual influence on the process, as well as validation of the proposed methods.

Materials and methods. To meet the research's set purpose, the following tasks were identified: choosing the most rational method for the quantitative determination of albendazole and praziquantel; confirming the absence of the mutual influence of APIs on the results obtained; and validating the selected methods of albendazole and praziquantel analysis.

Object of the research conducted included coated tablets “AP-helmin”, series 1-5.2021; pharmacopoeial standard sample (PSS) of albendazole, and PSS praziquantel. Quantitative determination of albendazole and praziquantel was conducted according to SPU, method 2.2.29.

Results. The article describes the conditions and stages of the quantitative determination of albendazole and praziquantel and the main indicators of method validation.

Conclusions. It was proven that quantification with the liquid chromatography method of both substances is validated, and the substances do not affect each other's analysis in the coated tablets "AP-helmin" following the project of QCM for this drug. All calculated parameters meet the required validation criteria

Author Biographies

Kateryna Semchenko, National University of Pharmacy

Doctor of Pharmaceutical Sciences, Professor

Department of Pharmaceutical Technology of Drugs

Liliia Vyshnevska, National University of Pharmacy

Doctor of Pharmaceutical Sciences, Professor

Department of Pharmaceutical Technology of Drugs

Volodymyr Iakovenko, National University of Pharmacy

Doctor of Pharmaceutical Sciences, Professor

Department of Industrial Pharmacy and Economics

Tetyana Kovalova, National University of Pharmacy

PhD, Associate Professor

Department of Pharmaceutical Technology of Drugs

Mykhailo Marchenko, National University of Pharmacy

PhD, Associate Professor

Department of Pharmaceutical Technology of Drugs

Yelizaveta Zuikina, National University of Pharmacy

PhD, Assistant

Department of Pharmaceutical Technology of Drugs

Yana Marchenko, National University of Pharmacy

PhD, Assistant

Department of Cosmetology and Aromalogy

References

  1. Semchenko, K., Vyshnevska, L., Polovko, N. (2018). Study of anthelmintic activity and acute toxicity of medicine of combined composition. ScienceRise: Pharmaceutical Science, 6 (16), 8–12. https://doi.org/10.15587/2519-4852.2018.151428
  2. Semchenko, K., Vyshnevska, L. (2020). Study of the specific activity of anthelmintic drug “Ap-helmin.” Ukrainian Biopharmaceutical Journal, 2 (63), 54–57. https://doi.org/10.24959/ubphj.20.271
  3. Semchenko, K. V., Vyshnevska, L. I. (2019). Pat. No. 124898 UA. Antyhelmintnyi zasib na osnovi albendazolu ta prazykvantelu. MPK: A61K 31/4184, A61K 31/47, A61P 33/00. No. a201910236; declareted: 07.10.2019, published: 08.12.2021, Bul. No. 49.
  4. European Pharmacopoeia (2021). Strasbourg: European Directorate for the Quality of Medicines & Health Care. Available at: https://pheur.edqm.eu/subhome/10-8
  5. State Pharmacopoeia of Ukraine. Vol. 1 (2015). Kharkiv: State Enterprise Ukrainian scientific pharmacopoeial centre of quality of drugs, 1128.
  6. Anil, W., Subhash, G., Roshan, I., Badri, P. N. (2008). Validated liquid chromatographic method for simultaneous estimation of albendazole and ivermectin in tablet dosage form. Indian Journal of Chemical Technology, 15, 617–620.
  7. Khanji, M., Kawas, G., Haroun, M., Rasheed, M. A., Sakur, A. A. (2020). Quantitative determination of albendazole forced degradation percentages by densitometric thin layer chromatographic method. Research Journal of Pharmacy and Technology, 13 (5), 2207–2213. https://doi.org/10.5958/0974-360x.2020.00396.0
  8. Kumari, N., Singh, B. (2019). Quality By Design: A systematic approach for the development of analytical method validation. Journal of Drug Delivery and Therapeutics, 9, 1006–1012.
  9. Fregonezi-Nery, M. M., Baracat, M. M., Kedor-Hackmann, É. R. M., Pinheiro, R. M. (2001). Determination of albendazole in oral suspension. Analytical Letters, 34 (8), 1255–1263. https://doi.org/10.1081/al-100104151
  10. Swamy, N., Basavaiah, K. (2014). Simple and rapid spectrophotometric assay of albendazole in pharmaceuticals using iodine and picric acid as CT complexing agents. Brazilian Journal of Pharmaceutical Sciences, 50 (4), 839–850. https://doi.org/10.1590/s1984-82502014000400019
  11. Refat, M. S., Mohamed, G. G., Fathi, A. (2011). Spectrophotometric Determination of Albendazole Drug in Tablets: Spectroscopic Characterization of the Charge‐transfer Solid Complexes. Chinese Journal of Chemistry, 29 (2), 324–332. https://doi.org/10.1002/cjoc.201190086
  12. Tella, A. C., Olabemiwo, O. M., Malwi, M. O., Obiyenwal, G. K. (2010). Developing a spectrophotometric method for the estimation of albendazole in solid and suspension forms. International Journal of Physical Sciences, 5, 379–382.
  13. Ahmed, D. A., Abdel-Aziz, O., Abdel-Ghany, M., Weshahy, S. A. (2018). Stability indicating determination of Albendazole in bulk drug and pharmaceutical dosage form by chromatographic and spectrophotometric methods. Future Journal of Pharmaceutical Sciences, 4 (2), 161–165. https://doi.org/10.1016/j.fjps.2018.02.001
  14. Ferencz, E., Kelemen, É.-K., Obreja, M., Sipos, E., Vida, S., Urkon, M., Szabó, Z.-I. (2021). Computer-assisted UHPLC method development and optimization for the determination of albendazole and its related substances. Journal of Pharmaceutical and Biomedical Analysis, 203, 114203. https://doi.org/10.1016/j.jpba.2021.114203
  15. Saini, G., Singh, B., Vyas, M., Durgapal, S., Rangra, N., Suttee, A. (2024). RP-HPLC method development and validation of Albendazole and its impurity. BIO Web of Conferences, 86, 01046. https://doi.org/10.1051/bioconf/20248601046
  16. Rashed, N. S., Zayed, S., Abdelazeem, A., Fouad, F. (2020). Development and validation of a green HPLC method for the analysis of clorsulon, albendazole, triclabendazole and ivermectin using monolithic column: Assessment of the greenness of the proposed method. Microchemical Journal, 157, 105069. https://doi.org/10.1016/j.microc.2020.105069
  17. Varghese, S., Vasanthi, P., Ravi, T. (2011). Simultaneous densitometric determination of ivermectin and albendazole by high-performance thin-layer chromatography. Journal of Planar Chromatography – Modern TLC, 24 (4), 344–347. https://doi.org/10.1556/jpc.24.2011.4.13
  18. Saleh, H., Schnekenburger, J. (1992). Determination of praziquantel and of praziquantel in tablets by gas–liquid chromatography. The Analyst, 117 (9), 1457–1460. https://doi.org/10.1039/an9921701457
  19. Mainardes, R. M., Cinto, P. O., Gremião, M. P. D. (2006). High-performance Liquid Chromatography Determination of Praziquantel in Tablets and Raw Materials. Acta Farmacutica Bonaerense, 25 (4), 567–570.
  20. Soto, C., Contreras, D., Orellana, S., Yañez, J., Toral, M. I. (2010). Simultaneous Determination of Albendazole and Praziquantel by Second Derivative Spectrophotometry and Multivariated Calibration Methods in Veterinary Pharmaceutical Formulation. Analytical Sciences, 26 (8), 891–896. https://doi.org/10.2116/analsci.26.891
Development and validation of a method for simultaneous quantitative determination of albendazole and praziquantel in coated tablets “AP-helmin”

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Published

2024-04-30

How to Cite

Semchenko, K., Vyshnevska, L., Iakovenko, V., Kovalova, T., Marchenko, M., Zuikina, Y., & Marchenko, Y. (2024). Development and validation of a method for simultaneous quantitative determination of albendazole and praziquantel in coated tablets “AP-helmin”. ScienceRise: Pharmaceutical Science, (2 (48), 62–73. https://doi.org/10.15587/2519-4852.2024.290350

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Section

Pharmaceutical Science