Rapid RP-HPLC optimization for efficient determination of nebivolol hydrochloride in bulk and tablet dosage form: application of Box-Behnken design

Abstract Background Nebivolol hydrochloride (NBH) is a β-blocker known for its vasodilatory effects. According to the literature, it is commonly used to treat hypertension. Detecting drug molecules in bulk and tablet forms using statistical design is of significant importance in analytical science. Therefore, the objective of this work was to apply statistical experimental design principles to analyze NBH, utilizing a Box-Behnken design (BBD) to optimize the mobile phase composition. Results In this work, NBH was separated using an Inertsil ODS-3 V column with an optimized mobile phase consisting of 40:60% v/v acetonitrile (ACN) and 0.1% trifluoroacetic acid (TFA) in HPLC-grade Milli-Q water. The flow rate was programmed at 1 mL/min, and the column oven temperature was set at 40 °C ± 1 °C. Here, measurement was performed at 282 nm, with a retention time (Rt) of 5.41 min. Analysis of NBH in the marketed tablet formulation (Nebistar 10 mg) showed that the percentage of the labeled claim was consistent with the actual label claim. Additionally, the established method was validated in accordance with ICH guidelines. Conclusion The liquid chromatographic procedure developed is precise, accurate, and reliable, as indicated by %RSD values of less than 2%. As a result, it demonstrates significant potential for broad application in the analysis of NBH in both bulk and tablet formulations. Graphical Abstract