Particularities of HPLC analysis of combined pharmaceutical forms
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CERENIUC, Alina, FORNEA, Daniela, UNCU, Livia. Particularities of HPLC analysis of combined pharmaceutical forms. In: Direcții de reformare a sistemului farmaceutic din perspectiva cursului european al Republicii Moldova, Ed. Ediția a 2-a, 28 aprilie 2023, Chişinău. Comrat: Universitatea de Stat din Comrat, 2023, Ediția a 2-a, pp. 140-141. ISBN 978-5-88554-205-0.
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Direcții de reformare a sistemului farmaceutic din perspectiva cursului european al Republicii Moldova
Ediția a 2-a, 2023
Conferința "Direcții de reformare a sistemului farmaceutic din perspectiva cursului european al Republicii Moldova"
Ediția a 2-a, Chişinău, Moldova, 28 aprilie 2023

Particularities of HPLC analysis of combined pharmaceutical forms

CZU: 615.2.074:543.544.5

Pag. 140-141

Cereniuc Alina, Fornea Daniela, Uncu Livia
 
”Nicolae Testemițanu” State University of Medicine and Pharmacy
 
 
Disponibil în IBN: 17 mai 2023


Rezumat

Introduction: HPLC analysis (High-Performance Liquid Chromatography) is an important analytical technique in the pharmaceutical industry, used for the separation, identification and quantification of components in pharmaceutical forms. This separation and detection technique is able to sense minute amounts of substance, which gives it great sensitivity, being based on the differences in affinity between the components and the mobile phase. Combined medicines containing two or more active principles are increasingly used in the therapy of various diseases. Ensuring their quality requires the application of accurate, sensitive and efficient analysis techniques [1]. Aim of the study: Evaluation of the particularities of analysis of combinations with fixed doses (FDC) by the HPLC method. Material and methods: Advanced bibliographic review using Medline, Environmental Issues & Policy Index, Environmental Sci & Pollution Mgmt, Scopus (Elsevier), Current Contents, Scirus databases. 91 bibliographic sources were evaluated. Results: The HPLC method has currently become one of the most selective separation and identification methods, with wide applicability in various fields of analysis. The evaluation of scientific publications on the studied topic allows highlighting some particularities regarding the FDC analysis. Each medicinal substance in the composition of FDC has its own physico-chemical properties: solubility, lipophilicity, pH, reactivity. In HPLC analyses, each component in the sample to be analyzed interacts individually with the adsorbent material, determining different flow rates. Several of the evaluated bibliographic sources (21%) pay attention to the selection process of the separation method, since the selection depends on the nature of the components, the evaluation matrix and the sensitivity of the used detector. In 97% of the sources, it is highlighted that the process of optimizing the separation conditions is particularly important: the choice of the mobile phase, the type of column, the temperature and the pH. Obviously, the analysis method must be validated in accordance with ICH (International Conference on Harmonization) norms to ensure the accuracy and reliability of the results. Most of the reviewed articles describe in great detail and argue the selection of the chromatographic detector, as component detection is essential in HPLC analysis. This is usually done by UV-VIS absorption, mass spectrometry or fluorescence detectors. The sensitivity of the detector and its selectivity can be critical for the identification and quantification of all components. In the process of HPLC analysis of FDC, the sample to be analyzed is compared with the reference sample or the compliance with the quality specifications of the product is verified. Apart from the multiple challenges related to the number of active principles, their nature and the present doses, the advantage of applying the HPLC method in FDC analysis is the ability to quickly quantify all components simultaneously, the method being efficient, accurate and reproducible. Conclusions: HPLC analysis is an important method in the analysis of combined pharmaceutical forms. To obtain accurate and reliable results, the unique characteristics of each formula must be taken into account and the analysis conditions must be optimized by adapting them to the properties of each component.

Cuvinte-cheie
HPLC analysis, combined drugs