VALIDATION OF A NOVEL RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF AMLODIPINE BESYLATE AND NEBIVOLOL HYDROCHLORIDE IN BULK AND PHARMACEUTICAL DOSAGE FORMS

摘要

This experimental work present the development and validation of a simple, rapid, accurate and precise RP-HPLC method for the simultaneous estimation of amlodipine besylate (AMB) and nebivolol hydrochloride (NBH) in bulk drug and pharmaceutical dosage forms. The chromatographic separation was carried out with AGILENT 1120 liquid chromatograph in an isocratic mode using Kromasil ODS column (250 x 4.6mm x 5μ particle size) with a mobile phase of mixed acetate Buffer pH 5: acetonitrile (60:40v/v) and the eluents were monitored at 268nm. The retention times of AMB and NBH were 5.26min and 6.84min respectively. The method was found to be linear over the concentration range of 5-25μg/ml for amlodipine besylate and 10-50μg/ml for nebivolol hydrochloride with a correlation coefficient of 0.999. The percentage recoveries of AMB and NBH were found to be 99.01-101.5 % and 99.2-101.0% respectively. The proposed RP-HPLC method was validated according to ICH guidelines and was employed for routine quality control analysis in bulk and combined dosage forms.