APPLICATION OF A SELECTIVE BONDED PHASE IN THE LIQUID CHROMATOGRAPHIC ASSAY OF ONDANSETRON HYDROCHLORIDE
AND ITS IMPURITIES.

ANDREEA VARVARA1*, CRINA - MARIA MONCIU2,
CORINA ARAMĂ2, CONSTATIN POPESCU1
1Raw Materials and Finished Products Control Department, National
Medicines Agency, Av. Sanatescu Street no. 48, Bucharest, Romania
2Analytical Chemistry Department, Faculty of Pharmacy, UMF Carol
Davila, Traian Vuia Street no. 6, Bucharest, Romania
*corresponding author: andreea.varvara@anm.ro


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Abstract:

The present paper reports a new HPLC method for the assay of ondansetron hydrochloride and its identified impurities in a chromatographic system using a YMC basic column.
YMC basic is a selective bonded, reverse-phase column developed by YMC Co. Ltd., Japan, designed for the analysis of basic compounds. It is obtained with an alternative bonding approach to reduce peak tailing, by bringing together a support containing neutral silanol groups, which have minimal interactions with ionisable compounds, and a novel bonded phase consisting of monomerically bonded C8 and smaller alkyl chains. This stationary phase has complementary selectivity to C8 and C18 materials and shows high resolution and good peak symmetry for basic compounds, without the need of an ion-pair reagent addition in the mobile phase..




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