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

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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

Issue

No. 2 (48) (2024)

Section

Pharmaceutical Science

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Copyright (c) 2024 Kateryna Semchenko, Liliia Vyshnevska, Volodymyr Iakovenko, Tetyana Kovalova, Mykhailo Marchenko, Yelizaveta Zuikina, Yana Marchenko

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