Abstract
The Aim: Treatment of helminthiases of the digestive system remains an actual task of the medicine and pharmacy worldwide. So, to meet the needs of the Ukrainian pharmaceutical market tablets based on albendazole and praziquantel were proposed. In order to establish the further production of the drug, studies were conducted on the development and validation of a method for the quantitative determination of one of the active substances – albendazole, in the presence of the second active substance praziquantel. Materials and Methods: The object of the study was samples of tablets under the conditional name “AP-helmin”. Albendazole was extracted from tablets with ethyl alcohol when heated, 0.1 M sodium hydroxide solution was added and the obtained sample was evaluated spectrophotometrically in the ultraviolet light (308 nm). The method was conducted meeting the requirements of State Pharmacopoeia of Ukraine, harmonized with the relevant European Pharmacopoeia techniques. Results: The samples comply with the Bouguer-Lambert-Behr law in the concentration range 1 × 10-3 - 1.2 × 10-2 mg/ml, the correlation coefficient is ≥ 0.9998. The studied method of quantitative determination of albendazole in the drug meets the criteria of acceptability for the range of determination ± 5.0 % by validation characteristics: specificity, linearity, precision, accuracy. The criterion of insignificance of the systematic error of the method is fulfilled – the systematic error of the method (0.24) is practically insignificant, that is, the method of analysis is characterized by sufficient correctness in the whole concentration range from 80 to 120 %. All the validation characteristics respond to the acceptance criteria. Conclusions: A method for the quantitative determination of albendazole in tablets “AP-helmin” by spectrophotometry in ultraviolet light (308 nm) was worked out. It was experimentally confirmed that the second active pharmaceutical ingredient (praziquantel) had no affect the accuracy of the results obtained.
Highlights
IntroductionThe diversity of biological species on Earth ensures their constant interaction with each other: useful (symbiosis, reciprocity, commensalism), neutral or harmful (competition, amensalism, allelopathy, predation, parasitism)
The diversity of biological species on Earth ensures their constant interaction with each other: useful, neutral or harmful
The purpose of our work is to develop and validate the quantitative determination of albendazole in tablets of combined composition by a spectrophotometric method, taking into account the presence of the second active pharmaceutical ingredient – praziquantel, and the influence of excipients
Summary
The diversity of biological species on Earth ensures their constant interaction with each other: useful (symbiosis, reciprocity, commensalism), neutral or harmful (competition, amensalism, allelopathy, predation, parasitism). Among the above types of interaction, parasitism is of particular interest to medicine, including the negative impact on the human body of protozoa, helminths, arthropods, etc., which leads to a significant reduction in the quality of life of patients and the development of reversible or irreversible consequences [1]. Digestive helminthiasis are of particular interest, as the most common group of parasitic diseases in most countries with non-tropical climates including Ukraine (currently, there are known about 70 species of helminths in Ukraine out of more than 250) [2]. As the pharmaceutical market in Ukraine does not currently meet the needs of patients to the full, we offered a drug in the form of tablets of combined composition with a proven broad spectrum of anthelminthic activity against the helminthiasis of the digestive system [3,4,5]
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