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ABSTRACT:
Development of new analytical methods for the determination of drugs in pharmaceutical dosage forms is more important in pharmacokinetic, toxicological and biological studies. Ezetemibe is a hypo-lipidaemic agent. Two simple and sensitive spectrophotometric methods (Method A and Method B) were developed for the estimation of Ezetemibe in bulk and pharmaceutical preparations. The two methods are based on the formation of yellow chromophores with PDAB and Picric acid exhibiting maximum absorption at 420nm and 400nm respectively. These two methods obey Beer's law in the concentration range of 10-50µg/ml and 10-30µg/ml respectively. The methods were validated for use in routine quality control studies of Ezetemibe. Interference studies were conducted and it was found that the common excipients usually present in dosage forms do not interfere in the proposed methods. The optical characteristics, regression analysis data and precision of the methods were calculated. The accuracy of the methods was evaluated by estimating the amount of Ezetemibe in previously analyzed samples to which known amounts of Ezetemibe were spiked. The accuracy of the methods was also confirmed by comparison of the results obtained by proposed and reference methods. The methods were validated for use in routine quality control of Ezetemibe in bulk and pharmaceutical preparations.
KEY WORDS: Ezetemibe, PDAB (Para dimethyl amino benzaldehyde), Picric acid, chromophores, absorption.
INTRODUCTION:
Ezetimibe is chemically (3R, 4S)-1-(P-fluorophenyl)-3-[(3)-3(P-fluorophenyl)-3-hydroxy phenyl] - 4- (p-hydroxyl phenyl)-2-azetidinone.(1,10) It is a hypolipaedemic agent. It is freely soluble in ethanol, methanol and acetone and practically insoluble in water. The presence of phenolic group and tertiary nitrogen enables the use of condensation reaction with PDAB (method...