DEVELOPMENT AND VALIDATION OF A NEW
CAPILLARY ZONE ELECTROPHORESIS
METHOD FOR THE ASSAY OF ONDANSETRON
CORINA ARAMĂ1, ANDREEA VARVARA2*, CRINA - MARIA
MONCIU1
1 Analytical Chemistry Department, Faculty of Pharmacy, UMF Carol
Davila, Traian Vuia Street no. 6, Bucharest, Romania
2 Quality of Medicines Control Department, National Medicines Agency,
Av. Sanatescu Street no. 48, Bucharest, Romania
*corresponding author: andreea.varvara@anm.ro
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Abstract:

An effective new capillary zone electrophoresis (CZE) assay has been developed for the determination of ondansetron hydrochloride and one of its impurities, ((3RS)-3- [(dimethylamino) methyl]-9- methyl- 1,2,3,9-tetrahydro -4H-carbazol -4-one) noted impurity A. Best resolution between the two analytes was achieved using a 35 mM phosphate buffer (pH 6.0) as running electrolyte, 20 kV applied voltage at 15°C, with direct UV detection at 216 nm; the migration times were 3.05 minutes and 3.3 minutes, respectively. The newly established method was validated with respect to linearity, precision, accuracy, selectivity, detection and quantitation limits.
The proposed CZE method is simple, fast and reliable, with convenient results in the assay of ondansetron and its impurity in pharmaceutical dosage forms (injectable solutions).

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