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Stability indicating method for evaluation of the active substance in pharmaceutical product
Burdová, Kateřina ; Kastner, Petr (advisor) ; Pilařová, Pavla (referee)
Charles University in Prague Faculty of Pharmacy in Hradec Králové Department of Pharmaceutical Chemistry and Drug Control Candidate: Mgr. Kateřina Burdová Supervisor: PharmDr. Petr Kastner, Ph.D. Title of thesis: Stability indicating method for evaluation of the active substance in pharmaceutical product A selective method for the determination of sodium picosulfate, its related substances and sodium benzoate using high-performance liquid chromatography was developed and validated. Separation of components was achieved with LiChroCART®, 250x4,0, Purospher® STAR, RP - 18C, 5μm column using UV detector at 263 nm. The mobile phase consisted of a buffer, acetonitrile and isopropyl-alcohol in the ratio of 55:43:2 (v/v/v). The buffer contained sodium dihydrogen phosphate, water R and cetyltrimethylammonium bromide. The pH value was adjusted by phosphoric acid to 7.0. The temperature of the column was 40 řC, injection volume 4 μl, the flow rate was adjusted to 1.0 ml/min. The method was evaluated as sufficiently selective, precise, accurate, linear and sensitive. Robustness was tested by means of Plackett-Burman design and it was found, that ratio of the acetonitrile in the mobile phase has the biggest influence on separation from all proved parameters. On the other hand, flow, buffer concentration and...
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