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Forced degradation study of 1-aminohydantoin hydrochloride using HPLC method
Benešová, Kamila ; Pilařová, Pavla (advisor) ; Kastner, Petr (referee)
CHARLES UNIVERSITY IN PRAGUE FACULTY OF PHARMACY IN HRADEC KRÁLOVÉ Department of Pharmaceutical Chemistry and Drug Control Chromatography center JSC OlainFarm, Latvia Author: Kamila Benešová Supervisor: PharmDr. Pavla Pilařová, Ph.D. Specialized supervisor: Natalija Vovka Title: Forced degradation study of 1-aminohydantoin hydrochloride using HPLC method Forced degradation, also called stress testing, is a helpful practice carried out in order to explore changes to a drug substance under excessive external stress condition. This thesis focuses on content and characteristics of forced degradation studies and description of the HPLC method in theoretical part and on the study conducted in JSC OlainFarm with the substance 1-Aminohydantoine hydrochloride (AHH) in the experimental part. There is only one known impurity 2-semicarbazidoacetic acid (SAA), which is a starting material and potential product of degradation. The aim of the study is to reveal the behavior and degradation pathways of AHH under stress testing. First, the samples of AHH were prepared and exposed to stress conditions which included pH, oxidation, light, heat, combination of heat and humidity. Then, they were analyzed by previously developed HPLC method which showed the decrease of the substance and possible presence of impurities....
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