<abstract xmlns="http://www.w3.org/1999/xhtml">

<sec><h3>Aim</h3>
<p>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.</p>
</sec>
<sec><h3>Materials and Methods</h3>
<p>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.</p>
</sec>
<sec><h3>Results</h3>
<p>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.</p>
</sec>
<sec><h3>Conclusion</h3>
<p>The proposed method is simple, rapid, accurate, precise and gives us knowledge about the pharmacokinetics and therapeutic drug monitoring in clinical laboratories.</p>
</sec>
</abstract>

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.

Development and Validation of Bioanalytical Method for Determination of Nebivolol and Valsartan in Human Plasma by Using RP-HPLC

European Pharmaceutical Journal

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...

Development and Validation of Bioanalytical Method for Determination of Nebivolol and Valsartan in Human Plasma by Using RP-HPLC

Article Category: Original Paper

Published Online: Mar 12, 2022

Page range: 49 - 58

Received: Apr 14, 2018

Accepted: Jun 01, 2018

DOI: https://doi.org/10.2478/afpuc-2021-0019

Keywords
Nebivolol, Valsartan, Atorvastatin, RP-HPLC, Method development, ICH Guidelines (ICH M10), Validation

© 2021 R. N. Kachave et al., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Development and Validation of Bioanalytical Method for Determination of Nebivolol and Valsartan in Human Plasma by Using RP-HPLC

Article Category: Original Paper

Published Online: Mar 12, 2022

Page range: 49 - 58

Received: Apr 14, 2018

Accepted: Jun 01, 2018

DOI: https://doi.org/10.2478/afpuc-2021-0019

KeywordsNebivolol, Valsartan, Atorvastatin, RP-HPLC, Method development, ICH Guidelines (ICH M10), Validation

© 2021 R. N. Kachave et al., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Keywords
Nebivolol, Valsartan, Atorvastatin, RP-HPLC, Method development, ICH Guidelines (ICH M10), Validation