alexa Abstract | Stability indicating RP-HPLC estimation of nebivolol hydrochloride in pharmaceutical formulations

Indian Journal of Pharmaceutical Sciences
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Research Paper Open Access

Abstract

A simple, specific, accurate and stability indicating reversed phase liquid chromatographic method was developed for the determination of nebivolol hydrochloride in tablet dosage forms. A phenomenex Gemini C-18, 5 mm column having 250×4.6 mm i.d., with mobile phase containing methanol: acetonitrile: 0.02 M potassium dihydrogen phosphate (60:30:10, v/v/v; pH 4.0) was used. The retention time of nebivolol hydrochloride was 2.6 min. The linearity for nebivolol hydrochloride was in the range of 0.2-10 mg/ml. The recovery was found to be in the range of 98.68-100.86%. The detection limit and quantification limit were found to be 0.06 mg/ml and 0.2 mg/ml, respectively. Nebivolol stock solutions were subjected to acid, alkali and neutral hydrolysis, chemical oxidation and dry heat degradation. The degraded product peaks were well resolved from the pure drug peak with significant difference in their retention time values. The proposed method was validated and successfully applied to the estimation of nebivolol hydrochloride in tablet formulations.

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Author(s): DA Shah KK Bhatt RS Mehta SL Baldania TR Gandhi

Keywords

Nebivolol hydrochloride (NEB), degradation, reversed phase liquid chromatography, stability indicating, validation

 
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