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Simplification of terbinafine HPLC analysis of samples based on biodegradable polyesters
Malovaná, Andrea ; Drastík, Martin (advisor) ; Kubíček, Vladimír (referee)
Charles University in Prague Faculty of Pharmacy in Hradec Králové Department of Biophysics and Physical Chemistry Candidate: Andrea Malovaná Supervisor: Ing. Martin Drastík, Ph. D. Diploma thesis: Simplification of terbinafine HPLC analysis of samples based on biodegradable polyesters A HPLC method for determination of terbinafine in samples consisting of copolymers of lactic and glycolic acid was optimized and validated. The development of the method was based on the finding of suitable chromatographic conditions for separation of terbinafine. The separation was performed on the Ascentis Express ES-CN, 15 cm × 4.6 mm; 2.7 μm core- shell column. The mixture of the citrate phosphate buffer pH 4 and acetonitrile in ratio 40:60 (v/v) was chosen as the mobile phase. The mobile phase flow rate was set to 1.4 ml/min and the temperature to 30 řC. The injection volume of samples containing terbinafine was 5 µl. The UV detection at 226 nm was employed. The retention time of terbinafine was 3.3 min. The whole analysis was completed within 4 min. The method was validated, following parameters were tested: column efficiency, factor of symmetry, LOD, LOQ, linearity, repeatability and robustness. Keywords: terbinafine, HPLC, core-shell column, PLGA
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Antifungal resistance mechanisms in dermatophytes
Kolarczyková, Daniela ; Hubka, Vít (advisor) ; Kuklová, Ivana (referee)
For the treatment of superficial fungal infections (dermatophytosis) is available a wide spectrum of antifungals from various chemical groups. These antifungals are mainly focused on various steps of ergosterol synthesis, thereby disrupting the cell membrane (allylamine, azole and morpholine antifungals) and on microtubule function (benzofuran antifungals). Despite the fact that the treatment of dermatophytosis is often associated with long-term exposure of the fungus to antifungals (weeks or months), until recently antifungal resistance in dermatophytes has been considered rare. However, current studies have shown the incidence of chronic infections, reinfection and treatment failures due to emerging resistance to some commonly used antifungals. The most serious problem today is the spread of resistance to terbinafine where the molecular principles are founded in the structural changes in the squalene epoxidase enzyme (SQLE). The increase in the incidence of this and other resistances is currently alarming especially in India, while the situation in Europe and America is in terms of dermatophyte susceptibility still quite favorable. The aim of this thesis is to summarize our knowledge of antifungal resistance in dermatophytes and their molecular principles. The thesis further summarizes the...
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Solid dispersions with terbinafine
Hluchníková, Nikola ; Šnejdrová, Eva (advisor) ; Dittrich, Milan (referee)
CHARLES UNIVERSITY Faculty of Pharmacy in Hradec Kralove Department of Pharmaceutical technology Name of the student: Nikola Hluchníková Title of diploma thesis: Solid dispersions with terbinafine Consultant: PharmDr. Eva Šnejdrová, PhD. The diploma thesis deals with the release of terbinafine base and terbinafine hydrochloride from degradable carrier in three different mediums. The carrier was polyester of lactic acid and glycolic acid branched on polyacrylic acid. The theoretical part is focused on the description of properties of drug substance and branched polyester, the bioavailability of poor soluble substances, the types of polymeric carriers and the release of drugs from solid dispersions, the thermal analysis of polymer, drug and the solid dispersion with the incorporated drug. In the experimental part, solid dispersions were prepared by the melting method, dissolution of the drug in water, phosphate buffer pH 5.5 and pH 7.4 were studied. The amount of released drug was determined spectrophotometrically at 223 nm and HPLC. A thermal analysis of polyester carriers and solid dispersions was performed by the DSC. The amount of drug released was affected by the pH of the environment. Prolonged release of terbinafine hydrochloride is carried out in a pH 7.4 phosphate solution. In case of...
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Simplification of terbinafine HPLC analysis of samples based on biodegradable polyesters
Malovaná, Andrea ; Drastík, Martin (advisor) ; Kubíček, Vladimír (referee)
Charles University in Prague Faculty of Pharmacy in Hradec Králové Department of Biophysics and Physical Chemistry Candidate: Andrea Malovaná Supervisor: Ing. Martin Drastík, Ph. D. Diploma thesis: Simplification of terbinafine HPLC analysis of samples based on biodegradable polyesters A HPLC method for determination of terbinafine in samples consisting of copolymers of lactic and glycolic acid was optimized and validated. The development of the method was based on the finding of suitable chromatographic conditions for separation of terbinafine. The separation was performed on the Ascentis Express ES-CN, 15 cm × 4.6 mm; 2.7 μm core- shell column. The mixture of the citrate phosphate buffer pH 4 and acetonitrile in ratio 40:60 (v/v) was chosen as the mobile phase. The mobile phase flow rate was set to 1.4 ml/min and the temperature to 30 řC. The injection volume of samples containing terbinafine was 5 µl. The UV detection at 226 nm was employed. The retention time of terbinafine was 3.3 min. The whole analysis was completed within 4 min. The method was validated, following parameters were tested: column efficiency, factor of symmetry, LOD, LOQ, linearity, repeatability and robustness. Keywords: terbinafine, HPLC, core-shell column, PLGA
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