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

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