Wednesday , 24 July 2024

Method Development and Validation for the Assay of Nebivolol Tablets by using RP-HPLC

1N. Kalpana Devi*, 2Pradeep Reddy, 3D.S.S.N. Neelima
1,2 Teegala Krishna Reddy College of Pharmacy, Hyderabad, Telangana State
3 Vikas Institite of Pharmaceutical Sciences, Rajahmundary

A simple, precise, and accurate gradient reversed-phase (RP)  high-performance liquid chromatographic (HPLC) assay method was developed and validated for determination of nebivolol in tablet dosage forms. gradient RP-HPLC separation was achieved on a Phenomenex, kinetex C18 column (75 mm X 4.6 mm id, 2.6 [micro]m particle size) using mobile Phase was prepared by two different solutions i.e solution A(pH 6 tetrabutyl ammonium hydrogen sulphate buffer: ACN-95:5) And solution B consists of (ACN : water -95:5).diluent was prepared by mixing buffer and methanol in the ratio of 50:50,at a flow rate of 1.2 mL/min, and detection was performed at 280 nm using a UV detector. The retention times was found to be 2.30 mins. The method was validated for specificity, linearity, precision, accuracy, robustness, and solution stability. The method was linear in the drug concentration range of 4-24 [micro]g/mL with a correlation coefficient of 0.999. The accuracy (recovery) was between 98.84 and 100.36%. The method precision for the determination of assay was 0.525% RSD. The method was specific for nebivolol. This newly developed method was successfully utilised for the quantitative estimation of drug in tablet dosage form

Keywords: Nebivolol, RP-HPLC, linearity, accuracy.

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