Development and Validation of Bioanalytical Method for Determination of Nebivolol and Valsartan in Human Plasma by Using RP-HPLC
Article Category: Original Paper
Pubblicato online: 12 mar 2022
Pagine: 49 - 58
Ricevuto: 14 apr 2018
Accettato: 01 giu 2018
DOI: https://doi.org/10.2478/afpuc-2021-0019
Parole chiave
© 2021 R. N. Kachave et al., published by Sciendo
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.
Aim
Nebivolol and valsartan are used in the treatment of hypertension. So, this study was conducted for the purpose of determining bioavailability/bioequivalence of nebivolol and valsartan in human plasma.
Materials and Methods
The chromatographic separation was performed on Symmetry C18 (150 × 4.6 mm, 5 μm) column using 0.01 N potassium dihydrogen phosphate (pH 3.0):acetonitrile (60:40) as the mobile phase at a flow rate of 1.0 mL/min and a detector wavelength of 280 nm. The retention times of nebivolol and valsartan in plasma were found to be 3.1 and 4.3 min, respectively.
Results
The method was validated statistically and by recovery studies. The linearity concentration was acceptable in the range of 0.5–10 ng/mL for nebivolol and 400–8000 ng/mL for valsartan. The lower limits of quantification were 0.5 ng/mL for nebivolol and 400 ng/mL for valsartan, which reached the levels of both drugs possibly found in human plasma. Per cent recoveries were obtained as 97.78% and 98.11% for nebivolol and valsartan, respectively.
Conclusion
The proposed method is simple, rapid, accurate, precise and gives us knowledge about the pharmacokinetics and therapeutic drug monitoring in clinical laboratories.