Journal of Chemical and Pharmaceutical Research (ISSN : 0975-7384)

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Original Articles: 2014 Vol: 6 Issue: 7

Liquid chromatographic method development and validation for assay and dissolution of nebivolol hydrochloride in tablet dosage form

Abstract

A simple, rapid, precise and accurate RP-HPLC method was developed and validated for dissolution profiling of Nebivolol Hydrochloride in tablet dosage forms. As per official records, the dissolution media for NebivololHCl Tablets is 900ml, 0.01 N HCl and for 45 Minutes time duration, on USP II (Paddle) Dissolution apparatus, at 50 RPM and at 37.0oC ± 0.5oC. The chromatographic development for Dissolution samples was achieved in a SHISEIDO CAPCELLPAK, CAP C-18, 4.6mm X 250mm, 5μ, (Column No AKAB06451) as a stationary phase and Methanol: Water (pH 3.0) in a ratio of 60:40 as eluent, at a flow rate of 1.0 ml/min. UV detection was performed at 280 nm. The retention time of Nebivolol Hydrochloride was found to be 4.9 min. The results of analysis were validated statistically and by recovery studies. Linearity, accuracy and precision were acceptable in the ranges of 5- 50μg/ml. The method was found suitable for Dissolution profiling and the results of Percentage Drug Release were within the USP Dissolution Limits.