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Sci. Pharm.
Volume 94
Issue 3
10.3390/scipharm94030081
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This is an early access version, the complete PDF, HTML, and XML versions will be available soon.
Article

UHPLC-UV Method for Vancomycin Quantification in Human Plasma by Simple Protein Precipitation: Development and Validation for Therapeutic Drug Monitoring

by
Joanne Palomino Saavedra
1,
Yina Pájaro González
2,
Donaldo de la Hoz Santander
3,
Edwin Enrique Tenorio Jiménez
4,
Orison Hernández Gámez
2 and
Gina Paola Domínguez Moré
1,5,*
1
Grupo de Investigación en Control y Tecnología Farmacéutica, Facultad de Química y Farmacia, Universidad del Atlántico, Puerto Colombia 081007, Colombia
2
Grupo de Investigación en Farmacia Asistencial y Farmacología, Facultad de Química y Farmacia, Universidad del Atlántico, Puerto Colombia 081007, Colombia
3
Fundación Hospital Universidad del Norte, Soledad 083001, Colombia
4
Blood Bank, Fundación Grupo de Estudio, Barranquilla 080020, Colombia
5
Centro de Servicios Farmacéuticos y Monitoreo de Fármacos, Facultad de Química y Farmacia, Universidad del Atlántico, Puerto Colombia 081007, Colombia
*
Author to whom correspondence should be addressed.
Sci. Pharm. 2026, 94(3), 81; https://doi.org/10.3390/scipharm94030081 (registering DOI)
Submission received: 17 August 2026 / Revised: 15 September 2026 / Accepted: 16 September 2026 / Published: 19 September 2026
Versions Notes

Abstract

Vancomycin (VCN) is a glycopeptide antibiotic widely used to treat Gram-positive infections such as those caused by methicillin-resistant Staphylococcus aureus (MRSA). Its narrow therapeutic window, high interindividual pharmacokinetic variability, and dose-dependent nephrotoxicity support the need for therapeutic drug monitoring (TDM). In this study, a UHPLC-UV method for VCN quantification in human plasma was developed and validated according to ICH M10 guidelines, using a one-step protein precipitation requiring only 100 µL of plasma. Clinical applicability was preliminarily explored in three hospitalized patients, where the area under the concentration-time curve over 24 h to minimum inhibitory concentration ratio (AUC24/MIC) was estimated using PrecisePK, NextDose, and TDMx Bayesian software platforms before and after dose adjustment. The method showed linearity from 0.5 to 100 µg/mL (r2 > 0.99), with accuracy within ±7% and precision below 11%. Acceptance criteria for selectivity and matrix effect were met, and stability was confirmed under multiple conditions, including clinically relevant storage and transport. Pre-adjustment AUC24/MIC values were outside the target window of 400–600 in all patients, confirming the pertinence of implementing model-informed precision dosing as a routine TDM practice in Colombian health institutions.
Keywords: vancomycin; UHPLC-UV; therapeutic drug monitoring; bioanalytical method validation; ICH M10; model-informed precision dosing; Bayesian dosing; AUC-guided monitoring vancomycin; UHPLC-UV; therapeutic drug monitoring; bioanalytical method validation; ICH M10; model-informed precision dosing; Bayesian dosing; AUC-guided monitoring

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MDPI and ACS Style

Palomino Saavedra, J.; González, Y.P.; Santander, D.d.l.H.; Tenorio Jiménez, E.E.; Hernández Gámez, O.; Domínguez Moré, G.P. UHPLC-UV Method for Vancomycin Quantification in Human Plasma by Simple Protein Precipitation: Development and Validation for Therapeutic Drug Monitoring. Sci. Pharm. 2026, 94, 81. https://doi.org/10.3390/scipharm94030081

AMA Style

Palomino Saavedra J, González YP, Santander DdlH, Tenorio Jiménez EE, Hernández Gámez O, Domínguez Moré GP. UHPLC-UV Method for Vancomycin Quantification in Human Plasma by Simple Protein Precipitation: Development and Validation for Therapeutic Drug Monitoring. Scientia Pharmaceutica. 2026; 94(3):81. https://doi.org/10.3390/scipharm94030081

Chicago/Turabian Style

Palomino Saavedra, Joanne, Yina Pájaro González, Donaldo de la Hoz Santander, Edwin Enrique Tenorio Jiménez, Orison Hernández Gámez, and Gina Paola Domínguez Moré. 2026. "UHPLC-UV Method for Vancomycin Quantification in Human Plasma by Simple Protein Precipitation: Development and Validation for Therapeutic Drug Monitoring" Scientia Pharmaceutica 94, no. 3: 81. https://doi.org/10.3390/scipharm94030081

APA Style

Palomino Saavedra, J., González, Y. P., Santander, D. d. l. H., Tenorio Jiménez, E. E., Hernández Gámez, O., & Domínguez Moré, G. P. (2026). UHPLC-UV Method for Vancomycin Quantification in Human Plasma by Simple Protein Precipitation: Development and Validation for Therapeutic Drug Monitoring. Scientia Pharmaceutica, 94(3), 81. https://doi.org/10.3390/scipharm94030081

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