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Development and validation of UHPLC method for determination of miconazole, econazole and its impurities in solid dispersions
 Arnoltová, Kristýna ; Matysová, Ludmila (advisor) ; Kujovská Krčmová, Lenka (referee)
Charles University Faculty of Pharmacy in Hradec Králové Department of Analytical Chemistry Candidate: Kristýna Arnoltová Supervisor: doc. PharmDr. Ludmila Matysová, Ph.D. Title of the diploma thesis: Development and validation of UHPLC method for determination of miconazole, econazole and its impurities in solid dispersions The aim of the submitted thesis was to create a new analytical method for the determination of miconazole, econazole and its three impurities. Ultra-high performance liquid chromatography (UHPLC) was used. A KinetexTM XB C18 column, 1.7 μm particle size, 50 x 2.1 mm was used for the separation. The mobile phase was composed of the acetate buffer pH 7.8 in a mixture with methanol (80:20) and of acetonitrile with methanol (60:40), in a total ratio of 60:40. A gradient elution was used. Flow rate was set to 0.6 ml / min. Butylparaben was chosen as the internal standard. All substances were detected at a wavelength of 225nm. Total analysis time was 9 minutes. After optimization of the separation conditions, the method was partially validated and used for practical measurements to determine the content of miconazole in solid dispersions.
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