Exploration of AQbD Approach for Development of RP-HPLC Method of Nebivolol

Background

Nebivolol hydrochloride (NBV) is a highly selective beta-adrenoceptor antagonist belonging to the third generation of beta-blockers. It is primarily utilized in the management of cardiovascular conditions. Since NBV is marketed in the tablet dosage form, ensuring its quality control and evaluation is important.

Objectives

Analytical Quality by Design (AQbD) is a novel tool for the optimization of chromatographic methods. The present study explores the AQbD approach for optimization of RP-HPLC method for analysis of Nebivolol (NBV).

Materials and Methods

In method development, Box-Behnken Design was used wherein mobile phase, wavelength and flow rate were considered as independent variables while retention time, peak area and tailing factor were responses. The optimized set of parameters was a mobile phase (MeOH:0.1% aqueous acetic acid in 71:29%v/v), flow rate of (0.8 mL/min) and wavelength (282 nm).

Results and Discussion

The method was found to be linear in a concentration range of 10 to 50 μg/mL with regression value (r²) of 0.999. The LOD and LOQ were obtained at concentration of 0.54 μg/mL and 1.64 μg/mL. The %RSD values for precision and robustness were found to be <2%. The % recovery was found to be 102.49% to 103.44% during accuracy study. Ruggedness of the method was confirmed by different analysts.

Conclusion

The optimized and validated RP-HPLC method, for NBV analysis, is robust and precise, making it suitable for routine use in pharmaceutical analysis.