UV Spectrophotometric Method Development and Validation for Estimation of Nebivolol hydrochloride as API and in Pharmaceutical Dosage Form

UV Spectrophotometric method is a common, delicate and very precise method used to be developed and validated for estimation of Nebivolol hydrochloride as API and pharmaceutical dosage form. The method is primarily depends on the measurement of the absorbance of Nebivolol hydrochloride concentrations in methanol: 0.01N HCl (10: 90) at 281nm in the wavelength reach about 200-400nm. The concentration range is 10-60 mu g/ml and obeyed the Beers law. The critical parameters of the calibration curve had been also calculated. The presence of frequent excipients in tablets does not affect the percentage recoveries results. The developed method was validated as per as ICH Q2 (R1) guidelines in terms of accuracy, precision, linearity, LOD and LOQ were found to be 1.955 mu g/ml and 5.925 mu g/ml respectively and the percentage of drug release shows the satisfactory result at 75 rpm with temperature 37 +/- 0.5 degrees C. This proposed method has been utilized effectively for the evaluation of the drug as API and its pharmaceutical formulations.