DEVELOPMENT AND VALIDATION OF A ROBUST RP-HPLC METHOD FOR ESTIMATION OF NEBIVOLOL IN MARKETED FORMULATION
Silkan J. Patel*
ABSTRACT
An accurate and sensitive RP-HPLC method has been developed for the measurement of Nebivolol (NEB) in its commercial formulation. The wavelength maximum for NEB was estimated to be 280 nm. RP-HPLC separations were conducted using a Phenomenex Gemini 5 µm C18 110 Å column (150 mm x 4.6 mm, 5 μm), with a mobile phase consisting of Methanol and KH2PO4 buffer at pH 4.5 (adjusted with a 5% Sodium Hydroxide solution) in a 55:45 ratio. The measurement was conducted at 280 nm with a UV detector, maintaining a flow rate of 1.3 ml/min and an injection volume of 20μl. The existing technique exhibits strong linearity within the range of 12.5-37.5 μg/ml for NEB. No influence from excipients was seen throughout the estimate. The suggested procedures were validated and found to be particular, accurate, and precise. The assay of NEB in the commercial formulation was determined to be 99.82%, indicating the correctness of the procedures used. The methods were efficiently used for the measurement of drug in pharmaceutical formulations, making them appropriate for routine quality control assessments.
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