Development of Stability Indicating Method for Chosen Pharmaceuticla Preparation II

Development of Stability Indicating Method for Chosen Pharmaceutical Preparation II Thesis Blanka Foltinská Charles University in Prague, Faculty of Pharmacy in Hradec Králové, Department of Pharmaceutical Chemistry and Drug Control Lamotrigine was exposed to such conditions to reach its degradation into degradation products which are also possible impurities of lamotrigine. A suitable method for separation of this impurities using HPLC was searched. Several chromatography columns were tested and the composition of mobile phase was optimized. Chromatography column Hypersil BDS, C18, 250 x 4,6 mm, 5 µm was chosen. Mobile phase was acetonitril : phosphate buffer 35:65, final pH of the mobile phase was adjusted to 7.0 by orthophosphoric acid. Flow rate was 1 ml/min, injected volume 20 µl, column temperature 40žC and UV detection at 309 nm. Linearity of this method was tested under these conditions