Studium problematiky stability léčivých přípravků metodou HPLC

• Main Author: Havlíková, Lucie
• Other Authors: Solich, Petr
• Format: Doctoral Thesis
• Language: Czech
• Published: 2006
• Online Access: http://www.nusl.cz/ntk/nusl-271878

"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...