METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF NEBIVOLOL HYDROCHLORIDE AND AMLODIPINE BESYLATE IN TABLET DOSAGE FORMS BY RP-HPLC

Abstract

A simple, specific and precise high performance liquid chromatographic method was developed and validated for Nebivolol HCl and Amlodipine besylate in a combined tablet dosage form. Nebivolol hydrochloride, a long acting, cardioselective β-blocker and Amlodipine besylate, a calcium channel blocker are considered in combination for the treatment of hypertension. The chromatographic separation was performed using Eclipse XDB plus C18 Column (4.6 × 150 mm, 5μm particle size). The mobile phase consisted of combination of 0.01 M Ammonium acetate buffer (pH 4.5) and Acetonitrile in the ratio of 50:50 v/v at a flow rate of 0.8 ml/min with the detection wavelength at 265 nm. Both the drugs showed good linearity in the concentration range of 10-50μg/ml and 5-25μg/ml respectively with a correlation coefficient of 0.999 for both drugs. The retention time for Nebivolol HCl and Amlodipine besylate were found to be 3.553 and 2.970 min respectively. The developed analytical method was validated for linearity, precision, accuracy, ruggedness, robustness, specificity and system suitability, which were within the acceptance limits according to ICH guidelines. The developed method can successfully be employed for routine quality control of Nebivolol HCl and Amlodipine besylate in combined tablet dosage forms.