Vývoj HPLC metody ke sledování stability amorfních látek

Číhalová, Daniela

Charles University in Prague Faculty of Pharmacy in Hradec Králové Department of Analytical Chemistry Candidate: Daniela Číhalová Supervisor: Prof. RNDr. Petr Solich, CSc., Prof. Seppo Auriola, MSc. Marko Lehtonen Title of diploma thesis: Development of HPLC method for assessment of stability of amorphous compounds Solid materials can be found in many diverse forms which are distinguishable by different properties. In my thesis, I focus on amorphous solids, their properties, significance, occurrence and, most of all, characterization. The most widely used methods are introduced and described, focusing on their practical use in characterizing polymorphic and amorphous compounds. During the preparation of an amorphous solid, rapid heating and cooling down occurs and therefore degradation can be expected. To prove thermal stability, an HPLC method has been developed and validated for the determination of concentration decrease of an active pharmaceutical ingredient in amorphous state of 8 compounds. The compounds (benzocaine, chlorpropamide, clotrimazole, furosemide, piroxicam, salicylic acid, thiosalicylic acid, and tolbutamide) were determined separately. The method was carried out on a reversed-phase column (1.8µm, 50 × 4.6 mm) maintained at 40řC. The mobile phase was acetonitrile-water containing...

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