Optimalizace a validace HPLC metody pro stanovení diklofenaku sodného a jeho degradačního produktu v tabletách

• Main Author: Birková, Agáta
• Other Authors: Matysová, Ludmila
• Format: Dissertation
• Language: Czech
• Published: 2012
• Online Access: http://www.nusl.cz/ntk/nusl-310878

Charles University in Prague, Faculty of Pharmacy in Hradec Králové Department of Analytical Chemistry Candidate: Agáta Birková Supervisor: PharmDr. Ludmila Matysová, Ph.D. Title of Diploma Thesis: Optimization and validation of HPLC method for the determination of sodium diclofenac and its degradation product in tablets This diploma thesis deals with the optimisation and the validation of the HPLC method determination of sodium diclofenac (DF) and its degradation product 1-(2,6-dichlorphenyl)-indolin-2-on (DPI) in tablets. DF is a non-steroidal anti-inflammatory drug with analgesic, antipyretic and anti-inflammatory effects. The degradation product DPI has been produced in formulations after a long-term storage, especially after exposure to light or heat. The method development was based on a method created by the Pharmaceutical Faculty of Charles University for the determination of DF, its degradation product and preservatives in topical emulgel and the method was optimised for determination of DF and DPI in tablets. The monolithic column Chromolith® Performance RP-18e (100×3 mm, Merck) and flurbiprofen as an internal standard were chosen. The mobile phase was prepared of methanol and aqueous solution of phosphoric acid (pH 2,5) in the ratio of 65:35 and the flow rate of 1 ml/min. An UV detector...