Method Development for Impurities in some Multicomponent Dosage Forms and Cardiovascular Drugs

Abstract

Chapter-1 is about general introduction of impurities and method development. newlineChapter-2 describes about an unknown impurity formed in 50°C stability samples at 3 months in Lamivudine, Zidovudine and Nevirapine tablets for oral suspension which was detected by the new HPLC method. This degradation product was isolated by using newlinepreparative chromatography. The chemical structure of the degradant was elucidated by MS, 1H-NMR, 13C-NMR, DEPT and IR. The data newlineindicated that the structure as 1-[5-Hydroxymethyl-4-(5-methyl-2,3- dihydro-[1,2,3]triazole-1yl)-tetrahydro-furan-2-yl]-5-methyl-1Hpyrimidine- 2,4-(1H,3H)-dione. The mechanism of formation of this newlineimpurity is described in detail