A systematic review on chromatography-based method validation for quantification of vancomycin in biological matrices

Area of Science:

• Analytical Chemistry
• Pharmacology
• Clinical Pharmacy

Background:

• Validated bioanalytical methods are essential for pharmacokinetic, bioequivalence studies, and therapeutic drug monitoring (TDM).
• Vancomycin exhibits high pharmacokinetic variability and a narrow therapeutic index, necessitating accurate quantification for effective TDM.

Purpose of the Study:

• To systematically review and identify published chromatographic bioanalytical methods for vancomycin quantification.
• To critically assess the method validation parameters of identified vancomycin bioanalytical methods against international guidelines.

Main Methods:

• A systematic literature search was conducted using PubMed and ScienceDirect databases.
• Selected studies were evaluated based on method validation criteria from international guidelines.

Main Results:

• Major deficiencies were identified in method validation parameters, including accuracy, precision, and the number of calibration and validation standards.
• These deficiencies compromise the reliability of the currently validated bioanalytical methods for vancomycin.

Conclusions:

• Published bioanalytical methods for vancomycin often lack robust validation, impacting TDM reliability.
• Adherence to recommended international guidelines for validation parameters is crucial to ensure reliable vancomycin bioanalysis.