Vývoj a validace HPLC metody pro stanovení 3-aminopropanolu a stabilitní studie farmaceutického přípravku

Dittrichová, Kateřina

Charles University in Prague Faculty of Pharmacy in Hradec Králové Department of Pharmaceutical Chemistry and Drug Analysis Student: Mgr. Kateřina Dittrichová Supervisor: RNDr. Milan Mokrý, CSc. Consultant: Ing. Lubomír Galla Title of rigorous thesis: Development and validation of an HPLC method for determination of 3-aminopropanol and stability study of pharmaceutical preparation A new method for the determination of 3-aminopropanol by high- performance liquid chromatography coupled with fluorescence detector was designed and developed. The method was based on derivatization of 3- aminopropanol with flurescamine in solution of sodium tetraborate decahydrate and subsequent formation of fluorescent derivative. Reversed-phase column Discovery C18 (5 µm, 150 mm × 4.6 mm I.D.) was employed. The fluorescence detector used two wavelengths: EM 483 nm and EX 390 nm. The suitable determination was carried out with an isocratic elution of mobile phase composed of acetonitrile and ammonium acetate buffer in the ratio 26:74 (v/v) in the 1.00 ml min-1 as the flow rate, and at the isocratic temperature mode of 30řC. Injection volume was 10 µl. The system suitability test (SST) was performed on three parameters: the retention time, method efficiency, and peak symmetry. The method was then fully validated. The...

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