Faculty of Pharmacy

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Author: search.filters.author.Acevska, JelenaEnd date: 2025

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    Dimethyl Isosorbide: An Innovative Bio-Renewable Solvent for Sustainable Chromatographic Applications
    (MDPI AG, 2025-06-24)
    Damjanoska, Aleksandra
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    Petrova, Matilda
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    The increasing environmental concerns and regulatory restrictions on toxic conventional solvents have driven the search for sustainable alternatives. Dimethyl isosorbide (DMI), a bio-renewable solvent, has shown potential as a replacement for short-chain glycol ethers, although its use as solvent in liquid chromatography (LC) is underexplored. This study presents a physicochemical characterization of DMI with a particular focus on its application as an innovative solvent in LC analyses. The partition coefficient (log P = −0.44) was determined using the OECD 107 method, and viscosity measurements for DMI and its mixtures with water and ethanol were conducted at 25 °C, 40 °C, and 60 °C. Viscosity ranged from 1.28 mPa·s at 60 °C to 2.62 mPa·s at 40 °C. The Central Composite Face 23 experimental design for studying the chromatographic behavior of DMI confirmed that 50% (v/v) DMI can be effectively utilized in the mobile phases, at a column temperature of 40 °C, with backpressures ranging from 160 to 300 bar and a UV cut-off at 240 nm. Its effectiveness as an eluent in LC was demonstrated for the quantification of methylparaben and propylparaben in pharmaceutical formulations. This study highlights DMI’s promise as a sustainable bio-renewable alternative to conventional organic solvents used as eluents in LC, supporting eco-friendly practices in pharmaceutical analysis.
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    Characterization of physicochemical properties of substances using chromatographic separation methods
    (Macedonian Pharmaceutical Association, 2020-10-29)
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    Green potentiometric method for determination of sildenafil citrate in pharmaceutical dosage forms
    (International Organization Of Scientific Research (IOSR), 2023-10)
    Irena Maksimoska,
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    Hrisanta Godzo,
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    Irena Slavevska Spirevska,
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    Background: The main challenge of the pharmaceutical industry in the last years is to implement eco-friendly methods in quality control of medicines based on the principles of green analytical chemistry. In this study, green analytical method for potentiometric titration of sildenafil citrate (SC) in film-coated tablets was optimized and validated. Materials and Methods: The quantitative determination of sildenafil citrate in film-coated tablets, dissolved in 50 mL 1% (v/v) Polysorbate 80 solution, was performed using potentiometric titration with 0.1 M sodium hydroxide. Validation of the method included linear regression analysis based on eleven different quantities of the sildenafil citrate, active substance and determination of specificity, precision and accuracy in accordance with ICH guideline. Results: The use of polysorbate 80 as a solubilization agent enabled elimination of the toxic organic solvents needed for non-aqueous potentiometric titration of active pharmaceutical ingredients with low solubility. The obtained results from method validation study confirm the linearity of the method. Statistical evaluation of the data obtained from regression analysis confirm that the method is acceptable for determination of the content of SC in API. The recovery values (98.0 % - 102.0 %), the obtained results for the relative standard deviation (below 0.5%) and F test confirm the accuracy and precision of the method. The results obtained from the method validation study comply to the defined acceptance criteria, confirming the applicability of the proposed method. Conclusion: The proposed method is applicable for determination of the content of SC in raw material, as well as in finished product (tablets). The method implements the principles of green analytical chemistry, providing one possible approach for overcoming the challenges of the pharmaceutical industry for transfer of non-green methods used in quality control into green and environment friendly methods.
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    Green RP-HPLC method for impurity profile of amlodipine in tablets
    (Centre for Evaluation in Education and Science (CEON/CEES), 2024)
    Gigopulu, Olga
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    Godzo, Hrisanta
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    Atanasovska, Biljana
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    Zafirova-Gjorgievska, Marija
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    <jats:p>Increased awareness of nature preservation has encouraged the introduction of the green analytical chemistry (GAC) practice concepts concerning several important aspects, including sustainable development, environmental impact, and minimum waste. The aim of this research was to contribute to the implementation of this approach for the pharmaceutical industry while retaining the crucial aspects and strict requirements of quality control of medicines. Therefore, an ethanolbased, green and robust high-performance liquid chromatography (HPLC) method for the determination of related substances of amlodipine (AML) in film-coated tablets was developed and optimized using the Design of Experiments (DoE). The chromatographic separation was performed on an RP-select B column (250 x 4.0 mm, 5 mm), using a mixture of 0.04 M sodium dihydrogen phosphate monohydrate (pH 4.0) and ethanol (60:40 % v/v) as a mobile phase. The optimized conditions provided the separation of two specified impurities (impurity D and impurity F). The selectivity of the method was confirmed using forced degradation studies. The Analytical Eco-scale approach and AGREE metrics confirmed that the method conforms to the GAC principles. The validated method was successfully applied for the determination of related substances in three samples from the market, demonstrating the applicability of the method in routine analysis.</jats:p>
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    Greenness Assessment and Validation of HPLC Method for Simultaneous Determination of Resveratrol and Vitamin E in Dietary Supplements
    (Oxford University Press (OUP), 2024-03-01)
    Topkoska, Marina
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    Miloshevska, Martina
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    Piponski, Marjan
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    Slaveska Spirevska, Irena
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    There is an increasing interest in the use of a combination of trans-resveratrol and vitamin E in dietary supplements. Determination of the content of both components is essential for confirmation of the quality of the product.
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    Green RP-HPLC method for impurity profile of amlodipine in tablets
    (Centre for Evaluation in Education and Science (CEON/CEES), 2024)
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    Godzo, Hrisanta
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    Atanasovska, Biljana
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    Zafirova-Gjorgievska, Marija
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    <jats:p>Increased awareness of nature preservation has encouraged the introduction of the green analytical chemistry (GAC) practice concepts concerning several important aspects, including sustainable development, environmental impact, and minimum waste. The aim of this research was to contribute to the implementation of this approach for the pharmaceutical industry while retaining the crucial aspects and strict requirements of quality control of medicines. Therefore, an ethanolbased, green and robust high-performance liquid chromatography (HPLC) method for the determination of related substances of amlodipine (AML) in film-coated tablets was developed and optimized using the Design of Experiments (DoE). The chromatographic separation was performed on an RP-select B column (250 x 4.0 mm, 5 mm), using a mixture of 0.04 M sodium dihydrogen phosphate monohydrate (pH 4.0) and ethanol (60:40 % v/v) as a mobile phase. The optimized conditions provided the separation of two specified impurities (impurity D and impurity F). The selectivity of the method was confirmed using forced degradation studies. The Analytical Eco-scale approach and AGREE metrics confirmed that the method conforms to the GAC principles. The validated method was successfully applied for the determination of related substances in three samples from the market, demonstrating the applicability of the method in routine analysis.</jats:p>
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    PLS based quantitative determination of insulin aspart in solution using Raman spectroscopy
    (Centre for Evaluation in Education and Science (CEON/CEES), 2024)
    Godzo, Hrisanta
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    <jats:p>The complex structure of medicines containing polypeptide active substances requires the implementation of challenging analytical approaches, based on physicochemical methods, and, where necessary, biological assays for quality control, as well as for the detection of substandard and falsified products. Vibrational spectroscopic techniques, including Raman spectroscopy, are fast, powerful, and non-destructive techniques which, when combined with multivariate chemometric modelling, can provide specific identification, quantitative determination, and insight into the secondary structure of proteins and peptides. The aim of this study was to investigate the possibility of using Raman spectroscopy as a screening method for quantification of pharmaceutical products containing active substances with polypeptide structures. For that purpose, a model based on partial least square (PLS) analysis for quantitative determination of insulin aspart in solution was developed using Raman spectroscopy. The proposed model enables the establishment of a rapid approach for screening of the quality of formulations containing active substances with polypeptide structure, providing the selection of suspected samples that should be further analysed using routine techniques, which are time-consuming and costly.</jats:p>
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    Screening the capability of vibrational spectroscopic techniques for simultaneous quantification of vitamins B1, B6, and B12 in a powder blend
    (Elsevier BV, 2024-07)
    Todorovski, Apostol
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    Petreska, Marina
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    Deconinck, Eric
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    Rebière, Hervé