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

<p>A sensitive and accurate high performance liquid chromatography method utilizing ultraviolet/visible light detection (HPLC-UV) for the quantification of Ribociclib in Spiked Human Plasma by HPLC-UV was developed and validated. Ribociclib (RCB) and the internal standard (IS), Trifluridine, were first extracted from plasma samples by a simple Protein Precipitation extraction using Acetonitrile. Plasma concentration of RCB and internal standard were then analyzed by applying reversed phase chromatography using Orochem orosil C18 (4.6 mm × 250 mm, 5 μ) and elution with a isocratic mobile phase consisting of 10 mM phosphate buffer – Acetonitrile (60:40, v/v) adjusted to pH 3.0 at a flow rate of 1.0 ml/min. Detection of RCB and the IS was subsequently done at a wavelength of 260 nm. The limit of quantification was 10 ng/ml. The calibration curve was linear (R2>0.998) over the concentration range of 10-1000 ng/ml. For human plasma, the accuracy and precision were within ±15% and ≤15%, respectively, for all concentrations, except for the lower limit of quantification, where they were within ≤20%.</p>
</abstract>

A sensitive and accurate high performance liquid chromatography method utilizing ultraviolet/visible light detection (HPLC-UV) for the quantification of Ribociclib in Spiked Human Plasma by HPLC-UV was developed and validated. Ribociclib (RCB) and the internal standard (IS), Trifluridine, were first extracted from plasma samples by a simple Protein Precipitation extraction using Acetonitrile. Plasma concentration of RCB and internal standard were then analyzed by applying reversed phase chromatography using Orochem orosil C18 (4.6 mm × 250 mm, 5 μ) and elution with a isocratic mobile phase consisting of 10 mM phosphate buffer – Acetonitrile (60:40, v/v) adjusted to pH 3.0 at a flow rate of 1.0 ml/min. Detection of RCB and the IS was subsequently done at a wavelength of 260 nm. The limit of quantification was 10 ng/ml. The calibration curve was linear (R2>0.998) over the concentration range of 10-1000 ng/ml. For human plasma, the accuracy and precision were within ±15% and ≤15%, respectively, for all concentrations, except for the lower limit of quantification, where they were within ≤20%.

Development and validation of a new bioanalytical method for quantification of CDK4/6 inhibitor in Spiked Human Plasma by HPLC-UV

Department of Pharmaceutical Chemistry, Bhujbal Knowledge City, MET’s Institute of Pharmacy

Affilated to Savitribai Phule Pune University

Current Issues in Pharmacy and Medical Sciences

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

A sensitive and accurate high performance liquid chromatography method utilizing ultraviolet/visible light detection (HPLC-UV) for the quantification of...

Development and validation of a new bioanalytical method for quantification of CDK4/6 inhibitor in Spiked Human Plasma by HPLC-UV

Published Online: Jun 30, 2023

Page range: 81 - 86

Received: Dec 12, 2022

Accepted: Jan 08, 2023

DOI: https://doi.org/10.2478/cipms-2023-0014

Keywords
bioanalytical methods, protein precipitation, validation, Spiked Human Plasma

© 2023 Rakesh U. Shelke et al., published by Sciendo

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

Development and validation of a new bioanalytical method for quantification of CDK4/6 inhibitor in Spiked Human Plasma by HPLC-UV

Published Online: Jun 30, 2023

Page range: 81 - 86

Received: Dec 12, 2022

Accepted: Jan 08, 2023

DOI: https://doi.org/10.2478/cipms-2023-0014

Keywordsbioanalytical methods, protein precipitation, validation, Spiked Human Plasma

© 2023 Rakesh U. Shelke et al., published by Sciendo

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

Keywords
bioanalytical methods, protein precipitation, validation, Spiked Human Plasma