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Problems of stability testing of the active substances and pharmaceutical preparations using HPLC
Havlíková, Lucie ; Solich, Petr (advisor) ; Jokl, Vladimír (referee) ; Sochor, Jaroslav (referee)
"Problems of Stability Testing of the Active Substances and Pharmaceutical Preparations Using HPLC" The presented thesis deals with using of high performance liquid chromatography for the analysis of pharmaceutical active substance, its degradation products, and impurities in pharmaceutical preparations. The theoretical part describes in a more detailed way the topic stability and impurity testing in pharmaceutical preparations. The HPLC theory, method optimization, isolation procedures, method validation, HPLC/MS, and UPLC are characterized briefly in separate chapters. The practical part of the thesis focuses mainly on the development and validation of new chromatographic methods for simultaneous determination of active substances, impurities, and preservatives in topical pharmaceutical preparations. Six original methods, which are used for the quality control and stability testing of pharmaceuticals, were developed and validated. The active substance indomethacin and two degradation products (5-methoxy-2- methylindoleacetic acid and 4-chlorobenzoic acid) were monitored in antiflogistic topical preparation Indomethacin gel (see attachment 5.2). For antimycotically active topical preparation Terbinafin cream, method for determination of the active substance terbinafine hydrochloride, degradation...
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Zirconia-based and Chiral Stationary Phases in Pharmaceutical Analysis
Kučera, Radim ; Sochor, Jaroslav (advisor) ; Blešová, Marie (referee) ; Pospíšilová, Marie (referee)
Disertační práce Summary High performance liquid chromatography achieved during its existence enormous boom. Modern, PC controlled and user-friendly chromatographic devices allow performing a number of tens analyses on one apparatus daily. There is possible to analyse wide spectrum of compounds from non-polar to polar and from low molecular to high molecular analytes. Appropriate choice of chromatographic column, mobile phase and detection technique makes the analysis of complicated mixtures possible and allow obtaining both qualitative and quantitative information. HPLC is due to these characteristics utilized not only in the field of pharmacy but also in other areas e.g. biology, medicine, industry, environment monitoring and quality control of various products. Separation column is the most important part of the chromatographic system. The availability of stable, high performance chromatographic phases is the essential requirement for the development of a rugged and reproducible method. Nowadays, most HPLC separations have been done in the reversed-phase mode on the silica-based columns. This phenomenon is due to many positive properties of silica - mechanical strength, well mastered manufacture of silica particles, easy modification of silica surface, compatibility with water rich mobile phases etc. The...
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